Work of Breathing in Nasal CPAP Versus High Flow Nasal Prong in Infants With Severe Acute Bronchiolitis

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.

Study Overview

• Status: Unknown
• Conditions: Bronchiolitis
• Intervention / Treatment: Device: glasses broadband; Device: nasal CPAP

• Study Type: Interventional
• Enrollment (Anticipated): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13354
    • Recruiting
    • Assistance Publique Hopitaux de Marseille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Exclusion Criteria:

• - 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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group A	Device: glasses broadband; Device: nasal CPAP
Experimental: group B	Device: glasses broadband; Device: nasal CPAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
calculation of the trans-diaphragmatic pressure	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the effectiveness of treatments	respiratory and hemodynamic parameters: ( Respiratory rate; Heart Rate; blood pressure; Clinical signs of struggle); haematosis ( SpO2 ; FiO2 ; transcutaneous PCO2 )	12 months

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Anticipated): March 1, 2015
• Study Completion (Anticipated): September 1, 2015

Study Registration Dates

• First Submitted: September 13, 2013
• First Submitted That Met QC Criteria: September 13, 2013
• First Posted (Estimate): September 18, 2013

Study Record Updates

• Last Update Posted (Estimate): August 28, 2014
• Last Update Submitted That Met QC Criteria: August 27, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis; Bronchiolitis
• Other Study ID Numbers: 2012-A01524-39; 2012-36 (Other Identifier: AP HM)