Implications of sedation during the use of noninvasive ventilation in children with acute respiratory failure (SEDANIV Study)
Authors: Bermúdez-Barrezueta Lorena , Mayordomo-Colunga Juan , Miñambres-Rodríguez María , Reyes Susana , Valencia-Ramos Juan , Lopez-Fernandez Yolanda Margarita , Mendizábal-Diez Mikel , Vivanco-Allende Ana , Palacios-Cuesta Alba , Oviedo-Melgares Lidia , Unzueta-Roch José Luis , López-González Jorge , Jiménez-Villalta María Teresa , Cuervas-Mons Tejedor Maite , Artacho González Lourdes , Jiménez Olmos Ainhoa , Pons-Òdena Martí , Brezmes Raposo Marta , Pino Vázquez María Asunción , Vivanco-Allende Ana , Mayordomo-Colunga Juan , Miñambres-Rodríguez María , Reyes-Domínguez Susana Beatriz , López Fernández Yolanda , Gorostizaga Zaloa , García Teresa María Ángeles , Rives Ferreiro María Teresa , Fernández-Lafever Sarah N. , González-Gómez José Manuel , Montero-Yéboles Raúl , Modesto i Alapont Vicente , Rodríguez-Núñez Antonio , Gutiérrez-Marqués Soraya , González-Benavides Aida , Fernández de Miguel Sira , González-Salas Elcira ,   SEDANIV Study group of the Spanish Society of Pediatric Intensive Care
Published: July 2024

Abstract
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 levels were documented at the time of NIV initiation, as well as at 3, 6, 12, 24, and 48 h. The COMFORT-behavior (COMFORT-B) scale was used to assess the patients’ level of comfort. NIV failure was considered to be a requirement for endotracheal 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 SpO2/FiO2 ratio than did those who did not receive sedation (non-sedation group). A significantly greater improvement in the COMFORT-B score at 3, 6, 12, and 24 h, heart rate at 6 and 12 h, and SpO2/FiO2 ratio at 6 h 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 h (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 h, SpO2 at 3 h, FiO2 at 12 h, 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.