Implications of Sedation During the Use of Non-invasive Ventilation in Children with Acute Respiratory Failure (SEDANIV Study)

Background : The objective of this study was to analyze the effects of sedation administration on clinical parameters, comfort status, intubation requirements, and the pediatric intensive care unit (PICU) length of stay (LOS) in children with acute respiratory failure (ARF) receiving noninvasive ventilation (NIV). Methods: Thirteen PICUs in Spain participated in a prospective, multicenter, observational trial from January to December 2021. Children with ARF under the age of five who were receiving NIV were included. Clinical information and comfort levelswere documented at the time of NIV initiation, as well as at 3, 6, 12, 24, and 48 hours. The COMFORT-behavior (COMFORT-B) scale was used to assess the patients’ level of comfort. NIV failure was considered to be a requirement forendotracheal intubation. Results : A total of 457 patients were included, with a median age of 3.3 months (IQR 1.3-16.1). Two hundred and thirteen children (46.6%) received sedation (sedation group); these patients had a higher heart rate, higher COMFORT-B score, and lower S/F ratio than did those who did not receive sedation (non-sedationgroup). A significantly greater improvement in the COMFORT-B score at 3, 6, 12, and 24 hours, heart rate at 6 and 12 hours, and S/F ratio at 6 hours was observed in the sedation group. Overall, the NIV success rate was 95.6% -intubation was required in 6.1% of the sedation group and in 2.9% of the other group (p =0.092). Multivariate analysis revealed that the PRISM III score at NIV initiation (OR 1.408; 95% CI 1.230–1.611) and respiratory rate at 3 hours (OR 1.043; 95% CI 1.009–1.079) were found to be independent predictors of NIV failure. The PICU LOS was correlated with weight, PRISM III score, respiratory rate at 12 hours, SpO2 at 3 hours, FiO2 at 12 hours, NIV failure and NIV duration. Sedation use was not found to be independently related to NIV failure or to the PICU LOS. Conclusions: Sedation use may be useful in children with ARF treated with NIV, as it seems to improve clinical parameters and comfort status but may not increase the NIV failure rate or PICU LOS, even though sedated children were more severe at technique initiation in the present sample.