Bronchiolitis, Respiratory Distress
Conditions
Keywords
Bronchiolitis, Esophageal pressure mesurement, Clinical score, Citical care, Infant
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.
Interventions
DEVICEInfantflow [EME, Brighton, England]
Sponsors
University Hospital, Montpellier
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 6 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Score (m-WCAS) [Hollman G, Shen G, Zeng L, et al. Crit Care Med 1998; 26:1731-1736] | — |
| Clinical score of respiratory distress at base line (H0) and at 6 hours (H6) | — |
| after the begining of the procedure. | — |
| The respiratory distress was evaluated with the modified Woods Clinical Asthma | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical items: respiratory and cardiac rate, average blood pressure at H0 and H6. | — |
| Manometric: Variation of esophageal pressure at H0 and H6. | — |
| Gasometric: Minimal FiO2 necessary to reach an oxygen saturation between 94 | — |
| and 98%, transcutanée PCO2, PaO2/FiO2 | — |
Countries
France
Outcome results
None listed