Informations générales (source: ClinicalTrials.gov)
Work of Breathing in Nasal CPAP Versus High Flow Nasal Prong in Infants With Severe Acute Bronchiolitis
Interventional
N/A
Assistance Publique Hopitaux De Marseille (Voir sur ClinicalTrials)
septembre 2013
septembre 2015
29 juin 2024
Nasal continuous positive airway pressure (nCPAP), widely used in neonatal intensive care
is also more and more used in infants with severe acute bronchiolitis. There is no
evidence that nCPAP improves outcome, but several studies showed that it reduces work of
breathing (WOB), improves gas exchange and decreases intubation rate. High flow nasal
prong (HFNP) therapy, also used in neonatal units, has recently been suggested for
bronchiolitis management. This technique allows warmed and moist gas administration
protecting nasal mucosa, and preventing variations of inspired gas FiO2. HFNP also
creates a continuous positive pressure, reducing WOB, and seems much more comfortable and
better tolerated by babies than nCPAP. There are no studies comparing both techniques for
bronchiolitis management. The main objective of this study is to compare WOB with nCPAP
and HFNP therapy in infants with severe bronchiolitis in pediatric intensive care unit.
Secondary purpose is to compare efficacy and tolerance of both techniques. We propose to
lead an open, single center, crossover randomized study. Each patient will receive the
two treatments. Three consecutive periods will be studied: first one (minimum 2 hours),
with the first technique CPAP or HFNP according to randomization (treatment 1); second
period (2 hours) with the second technique (treatment 2); Third period (6 hours) with the
second technique. The primary endpoint will be the comparison of WOB (estimated by the
calculation of the transdiaphragmatic pressure-time product) at the end of the two firsts
periods. Efficacy and tolerance of each technique will be evaluated and compared by
compared measuring respiratory rate, heart rate, FiO2, SpO2, transcutaneous PCO2,
modified Wood score, and EDIN score during the third period. Nine subjects by groups are
required.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Assistance Publique Hopitaux de Marseille - 13354 - Marseille - France | fabrice MiCHEL | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Infants less than 3 months
- Infants hospitalized in the pediatric intensive care unit of the hospital in
northern Marseille for an episode of acute viral bronchiolitis, defined by the
French consensus conference of 2000 (1) clinical signs of infection of the upper
airways with tachypnea, brake expiratory and / or wheezing auscultation, signs of
struggle
- Infants with acute respiratory distress score with Wood changed> 3 and requiring
ventilatory Support
- Infants whose parents or legal guardians have accepted their participation in the
research and signed informed consent.
- With Social Security
- Infants less than 3 months
- Infants hospitalized in the pediatric intensive care unit of the hospital in
northern Marseille for an episode of acute viral bronchiolitis, defined by the
French consensus conference of 2000 (1) clinical signs of infection of the upper
airways with tachypnea, brake expiratory and / or wheezing auscultation, signs of
struggle
- Infants with acute respiratory distress score with Wood changed> 3 and requiring
ventilatory Support
- Infants whose parents or legal guardians have accepted their participation in the
research and signed informed consent.
- With Social Security
-
- Clinical condition requiring immediate intubation before the start of treatment
to the:
- severity of respiratory distress: FiO2> 60% to maintain SpO2> 92%
- hemodynamic instability
- the occurrence of apneas désaturantes (respiratory pauses greater than 20
seconds duration associated with desaturation <80% and / or bradycardia
<80/min)
- the presence of neurological disorders with altered consciousness
- Presence of co-morbidities:
- chronic respiratory failure
- heart