Clincosm LogoSign in Get a demo

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

Sponsor
Assistance Publique Hopitaux De Marseille (Other)
Overall Status
Unknown status
CT.gov ID
NCT01944995
Collaborator
(none)
18
Enrollment
1
Location
2
Arms
24
Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: glasses broadband
  • Device: nasal CPAP
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
18 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Official Title:
Work of Breathing in Nasal CPAP Versus High Flow Nasal Prong in Infants With Severe Acute Bronchiolitis
Study Start Date :
Sep 1, 2013
Anticipated Primary Completion Date :
Mar 1, 2015
Anticipated Study Completion Date :
Sep 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: group B

Device: glasses broadband

Device: nasal CPAP
Experimental: group A

Device: glasses broadband

Device: nasal CPAP

Outcome Measures

Primary Outcome Measures

  1. calculation of the trans-diaphragmatic pressure [12 months]

Secondary Outcome Measures

  1. the effectiveness of treatments [12 months]

    respiratory and hemodynamic parameters: ( Respiratory rate; Heart Rate; blood pressure; Clinical signs of struggle) haematosis ( SpO2 ; FiO2 ; transcutaneous PCO2 )

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 3 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Assistance Publique Hopitaux de Marseille Marseille France 13354

Sponsors and Collaborators

  • Assistance Publique Hopitaux De Marseille

Investigators

  • Study Director: LOIC MONDOLONI, Assistance Publique Hopitaux De Marseille

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT01944995
Other Study ID Numbers:
  • 2012-A01524-39
  • 2012-36
First Posted:
Sep 18, 2013
Last Update Posted:
Aug 28, 2014
Last Verified:
Aug 1, 2014
Additional relevant MeSH terms:
Bronchiolitis

Study Results

No Results Posted as of Aug 28, 2014