Interest of Non Invasive Ventilation Versus Oxygen During the Intial Managment of Infant With Bronchiolitis Who Didn't Require Mechanical Ventilation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bronchiolitis
- Sponsor
- University Hospital, Montpellier
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- Clinical score of respiratory distress at base line (H0) and at 6 hours (H6)
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
The purpose of the study is to evaluate, in a prospective way, the clinical, the manometric an gazometric benefit of non-invasive ventilation (VNI), (INFANTFLOW [EME, Brighton, England]) during bronchiolitis of the infant compared to a conventional managment.
Detailed Description
1. Experimental plan: The infants (0 to 6 month) admitted in pediatric intesive care unit for respiratory distress with bronchiolitis but not requiring mechanical ventilation are randomized in two groups: group "A" is treated with a non-invasive ventilation device(Infantflow) during 6 hours, group "B" is treated conventionally by inhalation of a Air/O2 mixture during 6 hours. 2. Outcome: Primary outcome: clinical score of respiratory distress at H0 and H6. Secondary outcome: respiratory and cardiac frequency, average blood pressure. Manometric: Variation of esophageal pressure at H0, H6. Gasometric: Minimal FiO2 necessary to reach an oxygen saturation between 94 and 98%, transcutaneus PCO2, PaO2/FiO2 3. Analyze results: Intention to treat analysis after having checked the randomization by comparing clinical gravity in the two arms (clinical score). 4. Calendar of the study: October 2006 at April 2008 5. Follow-up of the patients: the study proceeds during the hospitalization of the infants during 6 hours and will not impose any specific follow-up.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Infant from 0 to 6 months admitted in the PICU
- •Clinical diagnosis: bronchiolitis
- •Signs of respiratory distress evaluated with a clinical score of respiratory distress \> 4
Exclusion Criteria
- •Cardiopathy, cystic fibrosis or a neuromuscular desease
- •Need for mechanical ventilation
Outcomes
Primary Outcomes
Clinical score of respiratory distress at base line (H0) and at 6 hours (H6)
The respiratory distress was evaluated with the modified Woods Clinical Asthma
after the begining of the procedure.
Score (m-WCAS) [Hollman G, Shen G, Zeng L, et al. Crit Care Med 1998; 26:1731-1736]
Secondary Outcomes
- Gasometric: Minimal FiO2 necessary to reach an oxygen saturation between 94
- and 98%, transcutanée PCO2, PaO2/FiO2
- Manometric: Variation of esophageal pressure at H0 and H6.
- Clinical items: respiratory and cardiac rate, average blood pressure at H0 and H6.