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Sleep disturbances and delirium are prevalent problems in the intensive care unit. Evidence suggests that these conditions negatively impact patient outcomes by increasing the length of hospital stays, delaying recovery, and raising healthcare costs.
This study aimed to investigate the effect of implementing a sleep care bundle on sleep quality and delirium among critically ill patients.
A quasi-experimental research design was used. A purposive sample of 66 patients was divided equally into two groups: a bundle group that received a sleep care bundle and a control group that received routine unit care in the chest intensive care units at Mansoura University in Egypt. Data were collected using the critically ill patients' outcome evaluation tool based on the Richards-Campbell Sleep Questionnaire Scale and the Intensive Care Delirium Screening Checklist.
Compared to the control group, the bundle group demonstrated statistically significant improvements across all sleep quality domains measured by the Richards-Campbell Sleep Questionnaire by Day 3. Specifically, sleep depth improved from 1.24 ± 0.44 to 1.82 ± 0.39 (effect size = 0.600), ability to fall asleep from 1.21 ± 0.42 to 1.91 ± 0.29 (effect size = 0.703), number of awakenings from 1.27 ± 0.45 to 1.79 ± 0.42 (effect size = 0.483), sleep efficiency from 1.24 ± 0.44 to 1.76 ± 0.44 (effect size = 0.600), and overall sleep quality from 1.24 ± 0.44 to 1.85 ± 0.36 (effect size = 0.600). In addition, the occurrence of delirium on Day 3 was significantly lower in the bundle group (0.0%) compared with the control group (15.2%) (χ 2 = 7.471, p = 0.023). Subsyndromal delirium was observed in 6.1% of the bundle group and 15.2% of the control group. The overall percentage of patients without delirium was significantly higher in the bundle group (93.9%) compared to the control group (69.7%).
Implementing a sleep care bundle enhances sleep quality and reduces the occurrence of delirium in critically ill patients. Therefore, it can be integrated as an adjunctive intervention alongside routine care for these patients. To strengthen future applications, incorporating fidelity monitoring is recommended to ensure consistent implementation of the sleep care bundle and to optimize its effectiveness in clinical practice.
Postoperative pulmonary complications (PPCs) are common after cardiac surgery and are associated with significant morbidity and mortality. Lung-protective ventilation strategies have been proposed to reduce PPCs, but the optimal level of positive end-expiratory pressure (PEEP) and the use of alveolar recruitment manoeuvres (RMs) remain controversial.
In this investigator-initiated, multicentre, open, randomised, parallel-group, superiority clinical trial, elective cardiac surgery patients at risk of PPCs will be assigned to one of two intraoperative ventilation strategies: (1) an open-lung ventilation strategy with protective ventilation, moderate PEEP and RMs or (2) a standard protective ventilation with low PEEP and no RM. The primary outcome will be a composite of prolonged (>24 hour) postoperative mechanical ventilation, reintubation for any cause or hospital-acquired pneumonia within 7 days of surgery, or death within 28 days of surgery. Data will be analysed on an intention-to-treat basis.
The VACARM (impact of intraoperatiVe moderAte positive end-expiratory pressure with reCruitment mAnoeuvres versus low positive end-expiRatory pressure on major postoperative pulMonary complications and death after on-pump cardiac surgery in high-risk patients) trial has been approved by an independent ethics committee for all study centres. Recruitment began in July 2021. Results will be published in international peer-reviewed medical journals.
ClinicalTrials.gov NCT04408495.
Cardiac surgery remains a high-risk procedure for bleeding despite advances in patient blood management. Conventional centrifugation-based autotransfusion devices primarily recover red blood cells, losing platelets and coagulation factors. The SAME autotransfusion device (i-SEP, Nantes, France) introduces an innovative filtration-based approach, recovering erythrocytes, leucocytes and platelets to enhance perioperative haemostasis. The main objective is to determine whether the filtration-based SAME device reduces significant perioperative bleeding compared with the centrifugation-based system in high-risk cardiac surgery patients.
The Centrifugation-based vs filtration-based intraOperative cell saLvage on qualiTy of peRioperAtive haemostasis iN cardiac surgEry (COLTRANE) trial is a multicentre, parallel-group, single-blinded, superiority-randomised clinical trial. Conducted over 19 months in 10 French hospitals, the study will target patients at high risk of bleeding undergoing on-pump cardiac surgery via sternotomy. A total of 570 patients (285 per group) are required to achieve 80% statistical power for detecting clinically significant differences. Eligible patients will be randomised to either a centrifugation-based or filtration-based autotransfusion group. Both groups will follow standardised perioperative and cardiopulmonary bypass management, with the devices used only intraoperatively. The primary outcome is the proportion of patients with clinically significant perioperative bleeding defined as classes 2 to 4 of the Universal Definition of Perioperative Bleeding. The secondary outcomes include device efficiency and safety, perioperative haemostasis, lengths of intensive care unit and hospital stays, early postoperative morbidity and 30-day all-cause mortality. Ancillary studies will be performed to evaluate cell recovery and washing performance, the viscoelastic properties of retransfused blood (Quantra Qplus; Stago, Asnières-sur-Seine, France), and the effect of salvaged leucocytes on postoperative inflammation and immune function.
This trial has received a favourable opinion from the Committee for the Protection of Persons and authorisation from the French authorities (Comité de protection des personnes Nord Ouest, IDRCB: 2023-A02566-39). Protocol V.1.1 was approved on 22 January 2024. The trial is registered on ClinicalTrials.gov (NCT06425614). The findings will be disseminated through oral communications at national and international scientific meetings and peer-reviewed journal publications. Individual participant data will be made available on reasonable request to qualified researchers, following review and approval by the study sponsor and ethics committee.
ClinicalTrials.gov, NCT06425614.
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