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Modified paediatric preoperative risk prediction score to predict postoperative ICU admission in children: a retrospective cohort study

Por: Lian · C. · Wang · P. · Fu · Q. · Du · X. · Wu · J. · Lian · Q. · ShangGuan · W.
Objective

To integrate intrinsic surgical risk into the paediatric preoperative risk prediction score (PRPS) model to construct a more comprehensive risk scoring system (modified PRPS) and improve the prediction accuracy of postoperative intensive care unit (ICU) admission in paediatric patients.

Design

This was a retrospective study conducted between 1 January and 30 December 2016. Data on age, American Society of Anaesthesiology physical status (ASA-PS), oxygen saturation, prematurity, non-fasted status, severity of surgery and immediate transfer to the ICU after surgery were collected. The modified PRPS was developed by logistic regression in the derivation cohort; it was tested and compared with the paediatric PRPS and ASA-PS by the Hosmer-Lemeshow test, the receiver operating characteristic (ROC) curve and Kappa analysis in the validation cohort.

Setting

Hospital-based study in China.

Participants

Paediatric patients (≤14 years) who underwent surgery under general anaesthesia were included, and those who needed reoperation due to surgical complications or stayed in the ICU preoperatively were excluded.

Main outcome measure

ICU admission rate, defined as any patients’ direct disposition from the operating room to the ICU immediately after the surgery.

Results

A total of 9261 paediatric patients were included in this study, with 418 patients admitted to the ICU. In the validation cohort, the modified PRPS model fit the test data well (deciles of risk goodness-of-fit 2=6.84, p=0.077). The area under the ROC curve of the modified PRPS, paediatric PRPS and ASA-PS were 0.963, 0.941 and 0.870, respectively (p

Conclusions

The modified PRPS integrating intrinsic surgical risk shows better prediction accuracy than the previous PRPS.

Phase II double-blind randomised controlled trial of exogenous administration of melatonin in chronic pain (DREAM--CP): a study protocol

Por: Adam · R. · Kanakarajan · S. · Onyeakazi · U. · Columb · M. · Galley · H.
Introduction

Chronic pain is prevalent, and approximately half of patients with chronic pain experience sleep disturbance. Exogenous melatonin is licensed to treat primary insomnia and there is some evidence for analgesic effects of melatonin.

The aim of this study is to investigate the effects of oral melatonin (as Circadin) 2 mg at night in adults with severe non-malignant pain of at least 3 months’ duration.

Methods and analysis

We will conduct a randomised double-blind placebo-controlled cross-over study. The primary outcome is sleep disturbance. Secondary outcomes are pain intensity, actigraphy, fatigue, reaction time testing, serum melatonin and endogenous opioid peptide levels along with patient views about study participation.

We aim to recruit 60 patients with severe chronic pain (average pain intensity ≥7 on the Brief Pain Inventory (BPI)) from a tertiary referral pain clinic in Northeast Scotland. Participants will be randomised to receive melatonin (as modified release Circadin) 2 mg daily for 6 weeks or placebo, followed by a 4-week washout period, then 6 weeks treatment with the treatment they did not receive. Participants will complete the Verran Snyder-Halpern Sleep Scale, Pittsburgh Sleep Quality Index, Pain and Sleep Questionnaire 3-item index, BPI and psychomotor vigilance reaction time testing at 6 points over 20 weeks. Actigraphy watches will be used to provide objective measures of sleep duration and latency and other sleep measures and will prompt patients to report contemporaneous pain and fatigue scores daily.

Cross-over analyses will include tests for effects of treatment, period, treatment–period interaction (carryover effect) and sequence. Within-patient effects and longitudinal data will be analysed using mixed linear models, accounting for potential confounders.

Ethics and dissemination

Approved by Office for Research Ethics Committees Northern Ireland, reference 19/NI/0007. Results will be published in peer-reviewed journals and will be presented at national and international conferences.

Trial registration number

ISRCTN12861060

'Organisation of delivery of care in operating suite recovery rooms within 48 hours postoperatively and patient outcomes after adult non-cardiac surgery: a systematic review

Por: Lloyd · C. · Ludbrook · G. · Story · D. · Maddern · G.
Context

Postoperative recovery rooms have existed since 1847, however, there is sparse literature investigating interventions undertaken in recovery, and their impact on patients after recovery room discharge.

Objective

This review aimed to investigate the organisation of care delivery in postoperative recovery rooms; and its effect on patient outcomes; including mortality, morbidity, unplanned intensive care unit (ICU) admission and length of hospital stay.

Data sources

NCBI PubMed, EMBASE and Cumulative Index to Nursing and Allied Health Literature.

Study selection

Studies published since 1990, investigating health system initiatives undertaken in postoperative recovery rooms. One author screened titles and abstracts, with two authors completing full-text reviews to determine inclusion based on predetermined criteria. A total of 3288 unique studies were identified, with 14 selected for full-text reviews, and 8 included in the review.

Data extraction

EndNote V.8 (Clarivate Analytics) was used to manage references. One author extracted data from each study using a data extraction form adapted from the Cochrane Data Extraction Template, with all data checked by a second author.

Data synthesis

Narrative synthesis of data was the primary outcome measure, with all data of individual studies also presented in the summary results table.

Results

Four studies investigated the use of the postanaesthesia care unit (PACU) as a non-ICU pathway for postoperative patients. Two investigated the implementation of physiotherapy in PACU, one evaluated the use of a new nursing scoring tool for detecting patient deterioration, and one evaluated the implementation of a two-track clinical pathway in PACU.

Conclusions

Managing selected postoperative patients in a PACU, instead of ICU, does not appear to be associated with worse patient outcomes, however, due to the high risk of bias within studies, the strength of evidence is only moderate. Four of eight studies also examined hospital length of stay; two found the intervention was associated with decreased length of stay and two found no association.

PROSPERO registration number

This protocol is registered on the International Prospective Register of Systematic Reviews (PROSPERO) database, registration number CRD42018106093.

Anaesthesia care providers employed in humanitarian settings by Medecins Sans Frontieres: a retrospective observational study of 173 084 surgical cases over 10 years

Por: Kudsk-Iversen · S. · Trelles · M. · Ngowa Bakebaanitsa · E. · Hagabimana · L. · Momen · A. · Helmand · R. · Saint Victor · C. · Shah · K. · Masu · A. · Kendell · J. · Edgcombe · H. · English · M.
Objective

To describe the extent to which different categories of anaesthesia provider are used in humanitarian surgical projects and to explore the volume and nature of their surgical workload.

Design

Descriptive analysis using 10 years (2008–2017) of routine case-level data linked with routine programme-level data from surgical projects run exclusively by Médecins Sans Frontières-Operational Centre Brussels (MSF-OCB).

Setting

Projects were in contexts of natural disaster (ND, entire expatriate team deployed by MSF-OCB), active conflict (AC) and stable healthcare gaps (HG). In AC and HG settings, MSF-OCB support pre-existing local facilities. Hospital facilities ranged from basic health centres with surgical capabilities to tertiary referral centres.

Participants

The full dataset included 178 814 surgical cases. These were categorised by most senior anaesthetic provider for the project, according to qualification: specialist physician anaesthesiologists, qualified nurse anaesthetists and uncertified anaesthesia providers.

Primary outcome measure

Volume and nature of surgical workload of different anaesthesia providers.

Results

Full routine data were available for 173 084 cases (96.8%): 2518 in ND, 42 225 in AC, 126 936 in HG. Anaesthesia was predominantly led by physician anaesthesiologists (100% in ND, 66% in AC and HG), then nurse anaesthetists (19% in AC and HG) or uncertified anaesthesia providers (15% in AC and HG). Across all settings and provider groups, patients were mostly healthy young adults (median age range 24–27 years), with predominantly females in HG contexts, and males in AC contexts. Overall intra-operative mortality was 0.2%.

Conclusion

Our findings contribute to existing knowledge of the nature of anaesthetic provision in humanitarian settings, while demonstrating the value of high-quality, routine data collection at scale in this sector. Further evaluation of perioperative outcomes associated with different models of humanitarian anaesthetic provision is required.

High-flow nasal oxygenation versus standard oxygenation for gastrointestinal endoscopy with sedation. The prospective multicentre randomised controlled ODEPHI study protocol

Por: Eugene · A. · Fromont · L. · Auvet · A. · Baert · O. · Mfam · W.-S. · Remerand · F. · Boulain · T. · Nay · M.-A.
Introduction

Hypoxaemia is a major complication during gastrointestinal endoscopy (GIE) procedures (upper/lower) when performed under deep sedation in the procedure room. Standard oxygen therapy (SOT) is used to prevent hypoxaemia. Data suggest that risk factors for hypoxaemia under deep sedation during GIE are obstructive sleep apnoea syndrome, a body mass index above 30 kg/m², high blood pressure, diabetes, heart disease, age over 60 years old, high American Society of Anesthesiologists physical status class and the association of upper and lower GIE. High-flow nasal oxygenation (HFNO) may potentially improve oxygenation during GIE under deep sedation. We hypothesised that HFNO could decrease the incidence of hypoxaemia in comparison with SOT.

Methods and analysis

The ODEPHI (High-flow nasal oxygenation versus standard oxygenation for gastrointestinal endoscopy with sedation. The prospective multicentre randomised controlled) study is a multicentre randomised controlled trial comparing HFNO to SOT during GIE (upper and/or lower) under deep sedation administered by anaesthesiologists in the procedure room. Three hundred and eighty patients will be randomised with a 1:1 ratio in two parallel groups.

The primary outcome is the occurrence of hypoxaemia, defined by a pulse oximetry measurement of peripheral capillary oxygen saturation (SpO2) below or equal to 92% during the GIE procedure. Secondary outcomes include prolonged hypoxaemia, severe hypoxaemia, need for manoeuvres to maintain upper airway patency and other adverse events.

Ethics and dissemination

This study has been approved by the ethics committee (CPP Sud Est Paris V, France), and patients are included after informed consent. The results will be submitted for publication in peer-reviewed journals. As provided for by French law, patients participating in the study are informed that they have the possibility to ask the investigators, once the study is completed, to be informed of the overall results of the study. Thus, a summary of the results will be sent by post to the participants on request.

Trial registration number

ClinicalTrials.gov Registry (NCT03829293).

Randomised controlled trial to investigate the relationship between mild hypercapnia and cerebral oxygen saturation in patients undergoing major surgery

Por: Wong · C. · Churilov · L. · Cowie · D. · Tan · C. O. · Hu · R. · Tremewen · D. · Pearce · B. · Pillai · P. · Karalapillai · D. · Bellomo · R. · Weinberg · L.
Objectives

The effects of hypercapnia on regional cerebral oxygen saturation (rSO2) during surgery are unclear. We conducted a randomised controlled trial to investigate the relationship between mild hypercapnia and rSO2. We hypothesised that, compared with targeted normocapnia (TN), targeted mild hypercapnia (TMH) during major surgery would increase rSO2.

Design

A prospective, randomised, controlled trial in adult participants undergoing elective major surgery.

Setting

A single tertiary centre in Heidelberg, Victoria, Australia.

Participants

40 participants were randomised to either a TMH or TN group (20 to each).

Interventions

TMH (partial pressure of carbon dioxide in arterial blood, PaCO2, 45–55 mm Hg) or TN (PaCO2 35–40 mm Hg) was delivered via controlled ventilation throughout surgery.

Primary and secondary outcome measures

The primary endpoint was the absolute difference between the two groups in percentage change in rSO2 from baseline to completion of surgery. Secondary endpoints included intraoperative pH, bicarbonate concentration, base excess, serum potassium concentration, incidence of postoperative delirium and length of stay (LOS) in hospital.

Results

The absolute difference between the two groups in percentage change in rSO2 from the baseline to the completion of surgery was 19.0% higher in both hemispheres with TMH (p2 was greater in the TMH group than the TN group throughout the duration of surgery. The difference between the groups became more noticeable over time. Furthermore, postoperative delirium was higher in the TN group (risk difference 0.3, 95% CI 0.1 to 0.5, p=0.02). LOS was similar between groups (5 days vs 5 days; p=0.99).

Conclusion

TMH was associated with a stable increase in rSO2 from the baseline, while TN was associated with a decrease in rSO2 in both hemispheres in patients undergoing major surgery. This resulted in a clear separation of percentage change in rSO2 from the baseline between TMH and TN over time. Our findings provide the rationale for larger studies on TMH during surgery.

Trial registration number

The Australian New Zealand Clinical Trials Registry (ACTRN12616000320459).

Comparison of the airway complications of subtypes of laryngeal mask airway and i-gel in child patients under general anaesthesia: a protocol for systematic review and network meta-analysis of randomised control trials

Por: Liu · J. · Xu · X. · Li · M. · Cai · R. · Yang · K.
Introduction

Laryngeal mask airway (LMA), an alternative to traditional tracheal intubation, is widely used in clinical practice and is considered to be an effective device for airway management. LMA and i-gel have been widely used in anaesthesia and emergency situations in children. Some systematic reviews have evaluated the efficacy of LMA and i-gel in children, but they have not shown consistent results in clinical performance. This study aims to evaluate the airway complications of all subtypes of LMA and i-gel in child patients under general anaesthesia using a Bayesian network meta-analysis (NMA).

Methods and analysis

PubMed, EMBASE.com, the Cochrane library, Web of Science and Chinese Biomedical Literature Database will be searched from inception to January 2019. We will include prospective randomised controlled trials (RCTs) that reported the subtypes of LMA and i-gel regardless of sample size. The risk of bias assessment of the included RCTs will be conducted according to the Cochrane Handbook V.5.1.0. A Bayesian NMA will be performed using WinBUGS V.1.4.3. Grading of Recommendations Assessment, Development and Evaluation will be used to explore the quality of evidence.

Ethics and dissemination

Ethics approval and patient consent are not required as this study is an NMA based on published trials. The results of this NMA will be submitted to a peer-reviewed journal for publication.

PROSPERO registration number

CRD42019127668.

Can network science reveal structure in a complex healthcare system? A network analysis using data from emergency surgical services

Por: Kohler · K. · Ercole · A.
Introduction

Hospitals are complex systems and optimising their function is critical to the provision of high quality, cost effective healthcare. Metrics of performance have to date focused on the performance of individual elements rather than the whole system. Manipulation of individual elements of a complex system without an integrative understanding of its function is undesirable and may lead to counterintuitive outcomes and a holistic metric of hospital function might help design more efficient services.

Objectives

We aimed to use network analysis to characterise the structure of the system of perioperative care for emergency surgical admissions in our tertiary care hospital.

Design

We constructed a weighted directional network representation of the emergency surgical services using patient location data from electronic health records.

Setting

A single-centre tertiary care hospital in the UK.

Participants

We selected data from the retrospective electronic health record data of all unplanned admissions with a surgical intervention during their stay during a 3.5-year period, which resulted in a set of 16 500 individual admissions.

Methods

We then constructed and analysed the structure of this network using established methods from network science such as degree distribution, betweenness centrality and small-world characteristics.

Results

The analysis showed the service to be a complex system with scale-free, small-world network properties. We also identified such potential hubs and bottlenecks in the system.

Conclusions

Our holistic, system-wide description of a hospital service may provide tools to inform service improvement initiatives and gives us insights into the architecture of a complex system of care. The implications for the structure and resilience of the service is that while being robust in general, the system may be vulnerable to outages at specific key nodes.

Hyperosmolar therapy for acute brain injury: study protocol for an umbrella review of meta-analyses and an evidence mapping

Por: Badenes · R. · Hutton · B. · Citerio · G. · Robba · C. · Aguilar · G. · Alonso-Arroyo · A. · Taccone · F. S. · Tornero · C. · Catala-Lopez · F.
Introduction

Acute brain injury is a challenging public health problem worldwide. Elevated intracranial pressure is a common complication after acute brain injury. Hyperosmolar therapy is one of the main therapeutic strategies for the management of intracranial hypertension. This study protocol outlines an umbrella review of meta-analyses which will investigate the benefits and harms of hyperosmolar therapy routinely used for the management of acute brain injury in the intensive care.

Methods and analysis

We will search PubMed/MEDLINE, EMBASE and the Cochrane Database of Systematic Reviews. We will include meta-analyses of primary research studies (eg, randomised controlled trials, observational studies or both) that evaluate one or more hyperosmolar solutions (including hypertonic saline and/or mannitol) for the treatment of adult patients with acute brain injury of any severity. Two researchers will independently screen all citations, full-text articles and abstract data. Potential conflicts will be resolved through discussion with a third researcher. Primary outcomes will be mortality and neurological outcomes at discharge. Secondary outcomes will include control of intracranial pressure, cerebral perfusion pressure, length of stay (in hospital an intensive care unit) and any adverse event. Quality of the included meta-analyses will be assessed using the AMSTAR-2 tool. An overall summary of methods and results will be performed using tabular and graphical approaches and will be supplemented by narrative description. We will analyse whether published meta-analyses present an outline of available evidence (eg, cited, described and discussed any previous meta-analysis). Where objectives from two or more meta-analyses overlap, we will assess the causes of any noted discrepancies between meta-analyses.

Ethics and dissemination

No ethical approval will be required. Findings from this study will be published in a peer-reviewed journal. All data will be deposited in a cross-disciplinary public repository.

PROSPERO registration number

CRD42019148152.

Ultrasound-guided superficial cervical plexus block for analgesia in patients undergoing craniotomy via suboccipital retrosigmoid approach: study protocol of a randomised controlled trial

Por: Peng · K. · Zeng · M. · Dong · J. · Yan · X. · Wang · D. · Li · S. · Peng · Y.
Introduction

Scalp nerve block has been proven to be an alternative choice to opioids in multimodal analgesia. However, for the infratentorial space-occupying craniotomy, especially the suboccipital retrosigmoid craniotomy, scalp nerve block is insufficient.

Methods and analysis

The study is a prospective, single-centre, randomised, paralleled-group controlled trial. Patients scheduled to receive elective suboccipital retrosigmoid craniotomy will be randomly assigned to the superficial cervical plexus block group or the control group. After anaesthesia induction, superficial cervical plexus nerve block will be performed under the guidance of ultrasound. The primary outcome is the cumulative consumption of sufentanil by the patient-controlled intravenous analgesia pump within 24 hours after surgery. Secondary outcomes include the cumulative consumption of sufentanil at other four time points and numerical rating scale pain severity score.

Ethics and dissemination

The protocol (version number: 2.0, 10 April 2019) has been approved by the Ethics Review Committee of China Registered Clinical Trials (Ethics Review No. ChiECRCT-20190047). The findings of this study will be disseminated in peer-reviewed journals and at scientific conferences.

Trial registration number

NCT04036812

Protocol for a systematic review of reporting standards of anaesthetic interventions in randomised controlled trials

Por: Elliott · L. · Coulman · K. · Blencowe · N. S. · Qureshi · M. · Watson · S. · Mouton · R. · Hinchliffe · R. J.
Introduction

There is significant variation in how anaesthesia is defined and reported in clinical research. This lack of standardisation complicates the interpretation of published evidence and planning of future clinical trials. This systematic review will assess the reporting of anaesthesia as an intervention in randomised controlled trials (RCT) against the Consolidated Standards of Reporting Trials for Non-Pharmacological Treatments (CONSORT-NPT) framework.

Methods and analysis

Online archives of the top six journals ranked by impact factor for anaesthesia and the top three general medicine and general surgery journals will be systematically hand searched over a 42-month time period to identify RCTs describing the use of anaesthetic interventions for any invasive procedure. All modes of anaesthesia and anaesthesia techniques will be included. All study data, including the type of anaesthetic intervention described, will be extracted in keeping with the CONSORT-NPT checklist. Descriptive statistics will be used to summarise general study details including types/modes of anaesthetic interventions, and reporting standards of the trials.

Ethics and dissemination

No ethical approval is required. The results will be used to inform a funding application to formally standardise general, local, regional anaesthesia and sedation for use in clinical research. The systematic review will be disseminated via peer-reviewed manuscript and conferences.

PROSPERO registration number

CRD42019141670.

Association of postoperative covert stroke and cognitive dysfunction among elderly patients undergoing non-cardiac surgery: protocol for a prospective cohort study (PRECISION study)

Por: Cui · Q. · Wang · D. · Zeng · M. · Dong · J. · Jin · H. · Hu · Z. · Zhang · Y. · Peng · Y. · Han · R.
Introduction

The incidence of covert stroke and cognitive dysfunction has gradually increased due to an ageing population. Recently, a prospective cohort study reported perioperative covert stroke was associated with an increased risk of postoperative cognitive dysfunction (POCD) 1 year after non-cardiac surgery. However, the mechanism remains unclear.

Methods and analysis

This is a prospective observational trial aiming to investigate the cumulative incidence of perioperative covert stroke and test the hypothesis that perioperative covert stroke associates with POCD in elderly patients undergoing non-cardiac and non-neurological surgery. Data on risk factors, brain MRI, cognitive function evaluation and serum immune-inflammatory cytokines will be collected and analysed.

Ethics and dissemination

Ethical approval has been granted by the Medical Ethics Committee of Beijing Tiantan Hospital, Capital Medical University (reference number: KY2017-027-02). The results of this study will be disseminated through presentations at scientific conferences and publication in scientific journals.

Trial registration number

NCT03081429.

Machine learning of physiological waveforms and electronic health record data to predict, diagnose and treat haemodynamic instability in surgical patients: protocol for a retrospective study

Por: Cannesson · M. · Hofer · I. · Rinehart · J. · Lee · C. · Subramaniam · K. · Baldi · P. · Dubrawski · A. · Pinsky · M. R.
Introduction

About 42 million surgeries are performed annually in the USA. While the postoperative mortality is less than 2%, 12% of all patients in the high-risk surgery group account for 80% of postoperative deaths. New onset of haemodynamic instability is common in surgical patients and its delayed treatment leads to increased morbidity and mortality. The goal of this proposal is to develop, validate and test real-time intraoperative risk prediction tools based on clinical data and high-fidelity physiological waveforms to predict haemodynamic instability during surgery.

Methods and analysis

We will initiate our work using an existing annotated intraoperative database from the University of California Irvine, including clinical and high-fidelity waveform data. These data will be used for the training and development of the machine learning model (Carnegie Mellon University) that will then be tested on prospectively collected database (University of California Los Angeles). Simultaneously, we will use existing knowledge of haemodynamic instability patterns derived from our intensive care unit cohorts, medical information mart for intensive care II data, University of California Irvine data and animal studies to create smart alarms and graphical user interface for a clinical decision support. Using machine learning, we will extract a core dataset, which characterises the signatures of normal intraoperative variability, various haemodynamic instability aetiologies and variable responses to resuscitation. We will then employ clinician-driven iterative design to create a clinical decision support user interface, and evaluate its effect in simulated high-risk surgeries.

Ethics and dissemination

We will publish the results in a peer-reviewed publication and will present this work at professional conferences for the anaesthesiology and computer science communities. Patient-level data will be made available within 6 months after publication of the primary manuscript. The study has been approved by University of California, Los Angeles Institutional review board. (IRB #19–0 00 354).

Accelerometery as a measure of modifiable physical activity in high-risk elderly preoperative patients: a prospective observational pilot study

Por: Grimes · L. · Outtrim · J. G. · Griffin · S. J. · Ercole · A.
Objectives

To use wrist-worn accelerometers (Axivity AX3) to establish normative physical activity (PA) and acceptability data for the high-risk elderly preoperative population, to assess whether PA could be modified by a prehabilitation intervention as part of routine care, to assess any correlation between accelerometer-measured PA and self-reported PA and to assess the acceptability of wearing wrist-worn accelerometers in this population.

Study design

Prospective, observational, pilot study.

Setting

Single National Health Service Hospital.

Participants

Frail patients≥65 years awaiting major surgery referred to a multidisciplinary preoperative clinic at which they received a routine intervention aimed at improving their PA. 35 patients were recruited. Average age 79.9 years (SD=5.6).

Primary outcomes

Normative PA data measured as a mean daily Euclidean norm minus one (ENMO) in milli-gravitational units (mg).

Secondary outcomes

Measure PA levels (mg) following a routine preoperative intervention. Determine correlation between patient-reported PA (measured using the Physical Activity Scale for the Elderly) and accelerometer-measured PA (mg). Assess acceptability of wearing a wrist-worn accelerometer measured using Visual Analogue Scale (VAS) questionnaire and device wear time (hours).

Results

Median baseline daily PA was 14.3 mg (IQR 9.75–22.04) with an improvement in PA detected following the intervention (median ENMO post intervention 20.91 mg (IQR 14.83–27.53), p=0.022). There was no significant correlation between accelerometer-measured and self-reported PA (baseline =0.162 (p=0.4), post intervention =–0.144 (p=0.5)). We found high acceptability ratings (median score of 10/10 on VAS, IQR 8–10) and wear-time compliance (163.2 hours (IQR 150–167.5) preintervention and 166.1 hours (IQR 162.5–167) post intervention).

Conclusions

Accelerometery is acceptable to this population and increases in PA levels measured following an unoptimised routine clinical intervention which indicates that health behavioural change interventions may be successful during the preoperative period. Accelerometers may therefore be a useful tool to design and validate interventions for improving PA in this setting.

Trial registration number

NCT03737903.

Investigator-initiated, multicentre, open-label, two-arm, randomised controlled trial comparing intubating conditions in 25{degrees} head-up position and supine: the InSize25 study protocol

Por: Falempin · A.-S. · Pereira · B. · Binakdane · F. · Bazin · J.-E. · Smirdec · M.
Introduction

Difficult airway management during tracheal intubation can lead to severe hypoxic sequelae. Routine intubation practice is to use a strict supine position, whereas a 25° head-up or reverse Trendelenburg position increases efficacy of preoxygenation, seems more comfortable for the anaesthetist and may also provide better intubation conditions in direct laryngoscopy. The 25° head-up position could be used for the whole population rather than only for obese patients, but there is no prospective randomised controlled trial with a robust design and large number of patients comparing strict supine against 25° intubation in operating room. The objective of the InSize25 study is to test the effect of these two patient positions on intubation conditions during laryngoscopy in scheduled surgery on non-obese patients.

Methods and analysis

InSize25 is an investigator-initiated, multicentre, open-label, two-arm, randomised controlled trial. The InSize25 study will randomise 1000 adult patients scheduled for surgery under general anaesthesia requiring intubation with neuromuscular-blocking drugs, candidates for direct laryngoscopy. The primary outcome variable is the view obtained during the first laryngoscopy without any external manipulation assessed using percentage of glottic opening. Important secondary outcomes are: Cormack-Lehane classification, number of attempts at laryngoscopy and at tracheal intubation, use of ancillary equipment (eg, bougies, alternative laryngoscope blades, videolaryngoscope) and manoeuvres (eg, laryngeal manipulation), comfort score for the anaesthetist, episodes of postinduction hypotension or desaturation and mechanical complications of intubation.

Ethics and dissemination

The trial received appropriate approval from the ‘CPP Sud-Est II’ ethical review board. Informed consent is required. If the 25° head-up position proves superior for tracheal intubation without more complications, it may become the routine-standard intubation position rather than only for use with obese patients. The final results will be published in a peer-reviewed journal.

Trial registration number

Clinicaltrials.gov identifier (NCT03339141).

Research protocol for mechanical complications after central venous catheterisation: a prospective controlled multicentre observational study to determine incidence and risk factors of mechanical complications within 24 hours after cannulation

Por: Adrian · M. · Borgquist · O. · Bentzer · P. · Akeson · J. · Spangfors · M. · Wrigstad · J. · Holmström · A. · Linner · R. · Kander · T.
Introduction

Central venous catheterisation is a common procedure in intensive care therapy and the use of central venous catheters is essential for treatment of many medical disorders. Although rare, central venous catheterisation is associated with mechanical complications that can be life-threatening if untreated. Real-time ultrasound guidance reduces the incidence of mechanical complications when compared with the anatomic landmark method. The purpose of this study is to determine the incidence of and potential risk factors associated with early mechanical complications of central venous catheterisation in an era where real-time ultrasound guidance has become clinical practice.

Methods and analysis

This is a prospective, controlled, multicentre, observational study. All participating hospitals follow the same clinical guidelines for central venous catheterisation. Each central venous catheter insertion will be recorded in the common electronic chart system according to a recently revised template. An automated script-based search will identify all recorded central venous catheter insertion templates during the study period and relevant variables will be extracted. Outcome measures and independent variables are pre-defined in this study protocol. Multivariable and univariable logistic regression analysis will be used to determine associations and risk factors of mechanical complications.

Ethics and dissemination

The Regional Ethical Review Board in Lund, Sweden has approved this study. The results will be submitted for publication in peer-reviewed medical journals and presented at national and international scientific meetings.

Trial registration number

NCT03782324.

Efficacy and safety of modified-release paracetamol for acute and chronic pain: a systematic review protocol

Por: Margan Koletic · Z. · Dosenovic · S. · Puljak · L.
Introduction

Paracetamol (acetaminophen) is widely used for management of mild-to-moderate pain and reduction of fever. It is available as immediate release (IR) and modified-release (MR) formulation. In 2017, European Medicines Agency recommended a suspension of marketing of MR paracetamol in the European Union. Benefit-risk balance of these products has been assessed as negative as data showed that existing procedures for overdose management may not be efficient. Since MR paracetamol is still available in other countries (Australia and USA) and there is no available systematic review (SR) of efficacy and safety of MR paracetamol in the literature, we have decided to perform one to evaluate available data from randomised clinical trials (RCTs).

Methods and analysis

Using predefined search criteria, we will search EMBASE, MEDLINE, Cochrane Central Register of Controlled Trials, ClinicalTrials.gov and WHO International Clinical Trials Registry Platform to identify RCTs evaluating efficacy and safety of MR paracetamol alone in any dose or duration for any pain. Participants are defined as adults and adolescents (over 12 years). Primary efficacy outcomes will be pain intensity, pain relief and sleep. Primary safety outcomes will be the number of patients experiencing any (serious) adverse event, the number of patients withdrawn due to adverse events and the number of patients with gastrointestinal and hepatic adverse events. Data analysis will be subdivided based on different clinical syndromes. Meta-analysis will be conducted if possible. Cochrane risk of bias (RoB) tool with seven dimensions will be used to assess RoB of individual studies.

Ethics and dissemination

This SR will include only data collected from trial reports; therefore, an ethical approval will not be sought. We will publish the protocol and our findings in peer-reviewed journals.

PROSPERO registration number

CRD42018115769.

High-flow oxygen for childrens airway surgery: randomised controlled trial protocol (HAMSTER)

Por: Humphreys · S. · von Ungern-Sternberg · B. S. · Skowno · J. · Williams · T. · Taylor · J. · Taverner · F. · Gibbons · K. · Burgoyne · L. · Sommerfield · D. · Stephens · P. · Hallett · B. · Vijayasekaran · S. · Slee · N. · Burns · H. · Sowa · M. · Davidson · A. · Schibler · A.
Introduction

Hypoxaemia during anaesthesia for tubeless upper airway surgery in children with abnormal airways is common due to the complexity of balancing adequate depth of anaesthesia with maintenance of spontaneous breathing and providing an uninterrupted field of view of the upper airway for the surgeon. High-flow nasal oxygenation (HIGH-FLOW) can prolong safe apnoea time and be used in children with abnormal airways but to date has not been compared with the alternative technique of low-flow nasal oxygenation (LOW-FLOW). The aim is to investigate if use of HIGH-FLOW can reduce the number of hypoxaemic events requiring rescue oxygenation compared with LOW-FLOW.

Methods and analysis

High-flow oxygen for children’s airway surgery: randomised controlled t rial (HAMSTER) is a multicentre, unmasked, randomised controlled, parallel group, superiority trial comparing two oxygenation techniques during anaesthesia. Children (n=530) aged >37 weeks to 16 years presenting for elective tubeless upper airway surgery who fulfil inclusion but not exclusion criteria will be randomised prior to surgery to HIGH-FLOW or LOW-FLOW post induction of anaesthesia. Maintenance of anaesthesia with HIGH-FLOW requires Total IntraVenous Anaesthesia (TIVA) and with LOW-FLOW, either inhalational or TIVA at discretion of anaesthetist. The primary outcome is the incidence of hypoxaemic events requiring interruption of procedure for rescue oxygenation by positive pressure ventilation and the secondary outcome includes total hypoxaemia time, adverse cardiorespiratory events and unexpected paediatric intensive care admission admission. Hypoxaemia is defined as Sp02

Ethics and dissemination

Ethical approval has been obtained by Children’s Health Queensland Human Research Ethics Committee (HREC/18/QRCH/130). The trial commenced recruitment in 2018. The primary manuscript will be submitted for publication in a peer-reviewed journal.

Trial registration number

The HAMSTER is registered with the Australia and New Zealand Clinical TrialsRegistry: ACTRN12618000949280.

Inguinal hernia repair in preterm neonates: is there evidence that spinal or general anaesthesia is the better option regarding intraoperative and postoperative complications? A systematic review and meta-analysis

Por: Dohms · K. · Hein · M. · Rossaint · R. · Coburn · M. · Stoppe · C. · Ehret · C. B. · Berger · T. · Schälte · G.
Objectives

Whether spinal anaesthesia (SA) reduces intraoperative and postoperative complications compared with general anaesthesia (GA) was investigated.

Design

The meta-analysis was structured based on the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) statement. Databases (PubMed, MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials and Web of Science) were searched, and four randomised controlled trials (RCTs) and two retrospective cohort studies were included. A random-effects model with pooled risk ratios and mean differences with 95% CIs were used. Statistical heterogeneity was evaluated using the I2 statistic. Quality assessment of the studies was performed by assessing the risk of bias according to the Cochrane and GRADE methodology.

Setting

Publications from January 1990 to November 2018 were included.

Participants and interventions

Our study selection captured information from studies focusing on neonates born before the 37th gestational week who were scheduled for an inguinal hernia repair operation under either SA or GA.

Primary and secondary outcome measures

The primary outcome measures were apnoea, postoperative ventilation and method failure rates according to predefined eligibility criteria. The duration of surgery, desaturation events

Results

We found significantly fewer events for the outcomes ‘any episode of apnoea’ and ‘mechanical ventilation postoperatively’ in the SA group. Bradycardias were significantly less common in the SA group. In total, 7.5% of the SA group were converted to GA. The duration of surgery was significantly shorter in the SA group. No significant differences were found in the outcome measures ‘postoperative oxygen supplementation’, ‘prolonged apnoea’, ‘postoperative oxygen desaturation

Conclusions

We consider SA a convenient alternative for hernia repair in preterm infants, providing more safety regarding postoperative apnoea. To the best of our knowledge, this is the first meta-analysis to include studies exclusively comparing SA versus GA. More high-quality RCTs are needed.

Trial registration number

CRD42016048683

Sedation versus general anaesthesia in endovascular therapy for anterior circulation acute ischaemic stroke: the multicentre randomised controlled AMETIS trial study protocol

Por: Chabanne · R. · Fernandez-Canal · C. · Degos · V. · Lukaszewicz · A.-C. · Velly · L. · Mrozek · S. · Perrigault · P.-F. · Molliex · S. · Tavernier · B. · Dahyot-Fizelier · C. · Verdonk · F. · Caumon · E. · Masgrau · A. · Begard · M. · Chabert · E. · Ferrier · A. · Jaber · S. · Bazin · J.-
Introduction

Endovascular thrombectomy is the standard of care for anterior circulation acute ischaemic stroke (AIS) secondary to emergent large vessel occlusion in patients who qualify. General anaesthesia (GA) or conscious sedation (CS) is usually required to ensure patient comfort and avoid agitation and movement during thrombectomy. However, the question of whether the use of GA or CS might influence functional outcome remains debated. Indeed, conflicting results exist between observational studies with better outcomes associated with CS and small monocentric randomised controlled trials favouring GA. Therefore, we aim to evaluate the effect of CS versus GA on functional outcome and periprocedural complications in endovascular mechanical thrombectomy for anterior circulation AIS.

Methods and analysis

Anesthesia Management in Endovascular Therapy for Ischemic Stroke (AMETIS) trial is an investigator initiated, multicentre, prospective, randomised controlled, two-arm trial. AMETIS trial will randomise 270 patients with anterior circulation AIS in a 1:1 ratio, stratified by centre, National Institutes of Health Stroke Scale (≤15 or >15) and association of intravenous thrombolysis or not to receive either CS or GA. The primary outcome is a composite of functional independence at 3 months and absence of perioperative complication occurring by day 7 after endovascular therapy for anterior circulation AIS. Functional independence is defined as a modified Rankin Scale score of 0–2 by day 90. Perioperative complications are defined as intervention-associated arterial perforation or dissection, pneumonia or myocardial infarction or cardiogenic acute pulmonary oedema or malignant stroke evolution occurring by day 7.

Ethics and dissemination

The AMETIS trial was approved by an independent ethics committee. Study began in august 2017. Results will be published in an international peer-reviewed medical journal.

Trial registration number

NCT03229148.

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