Patients in intensive care units (ICUs) frequently require mechanical ventilation, with approximately half needing invasive ventilation through an orotracheal tube. For these patients, gastric tube (GT) insertion is routinely performed to administer nutrition and medications or to drain gastric contents. The insertion route (oral or nasal) may affect the incidence of ventilator-associated pneumonia (VAP), a significant ICU care complication. This study aims to compare the impact of oral versus nasal GT insertion on the incidence of VAP in intubated ICU patients.
The SONG trial (NCT 05915663) is a multicentre, open-label, two-period, two-intervention, cluster randomised crossover superiority trial. 16 French ICUs will participate. ICUs will be randomised to periods of nasogastric or orogastric tube placement. The trial includes a practice standardisation period, followed by two 12-month inclusion periods separated by a monitoring and washout period. The primary endpoint is the incidence rate of VAP at day 28, confirmed by three independent physicians. Secondary endpoints include the ease of GT insertion, measured by the number of attempts.
This study received approval from a central ethical review board on 12 April 2024 (CPP Sud-est VI, registration number 23.00943.000175). Patients are included after informed consent or, when not possible, from next of kin. If none are available, the investigator will proceed with emergency inclusion, following French law. When consent is initially obtained from the next of kin or through emergency inclusion, the investigator will seek consent from the patient as soon as possible. Data will be anonymised and patient confidentiality maintained. Results will be published in peer-reviewed journals and presented at scientific meetings.
Severe perinatal asphyxia at term or near term remains a critical public health issue, associated with high risks of neonatal death and hypoxic-ischaemic encephalopathy (HIE). Despite improved clinical guidelines, suboptimal care persists in many cases, and previous audits have demonstrated that up to 50% of asphyxia cases could be associated with suboptimal care. OptiNeoCare is a French study which aims to assess the prevalence and determinants of suboptimal obstetric and neonatal care and evaluate its potential impact on neonatal outcomes.
This prospective, population-based observational study will include newborns ≥36 weeks’ gestation with severe perinatal asphyxia across 12 French perinatal networks (213 maternity units). Inclusion criteria comprise neonatal death or moderate/severe HIE with confirmed biochemical markers of asphyxia. Data will be collected prospectively from labour wards, transport teams and neonatal intensive care units using an electronic case report form, and the in-situ team will be invited to complete a morbi-mortality review (MMR). Approximately 336 cases will be included over 12 months, with 25% randomly selected for confidential enquiry by two experts. The quality of care will be assessed based on a structured classification of medical errors (diagnostic, therapeutic, preventive and systemic) by a panel of experts including an obstetrician or midwife and a paediatrician. Root cause analysis will identify determinants of suboptimal care. A concordance analysis will compare findings from MMRs and confidential enquiries. Statistical analysis will include multivariable logistic regression to explore associations between care quality and neonatal outcomes.
Ethical approval was granted by the Ethics Committee for Research in Obstetrics and Gynaecology. Informed non-opposition is required from participants. Results will be shared with participating centres, healthcare professionals and through scientific dissemination.
ClinicalTrials.gov ID: NCT06322732.
Systemic immune-inflammation index (SII) is a biomarker of inflammatory conditions; however, no scoring system has been evaluated for predicting mortality in patients with renal failure in intensive care unit (ICU). This study aimed to determine associations between SII level and mortality in patients with renal failure.
Using the Medical Information Mart for Intensive Care IV (V.2.0) database (USA), this retrospective study included 837 patients who were admitted to ICU with end-stage renal disease (ESRD), between 2008 and 2019.
Cox proportional-hazards models were used to evaluate correlations between SII and outcomes, expressing results as hazard ratios (HRs) with 95% confidence intervals (95% CIs). Regression analysis was used to determine associations between variables and SII.
In total, 837 adult patients from a total of 76 943 patients admitted to ICU were included, comprising 59.60% males with mean age 62.27±14.9 years and mean BMI 28.36±7.43 Kg/m2. Using median SII (1628 X 109 /L) as cut-off value, high (≥ 1628X109 /L) SII was also associated with an increased risk of ICU mortality (HR 1.97 (95% CI 1.15 to 3.35), p=0.034), in-hospital mortality (HR 1.95 (95% CI 1.23 to 3.09), p=0.017) and total mortality (HR 1.30 (95% CI 1.07 to 1.58), p=0.024).
SII may predict mortality in critically ill patients admitted to ICU with ESRD. SII ≥ 1628x109 /L correlates significantly with increased ICU mortality, in-hospital mortality and total mortality.