N/A
N=32
Heated Humidified Oxygen Compared to Dry Oxygen Therapy in Children With Bronchiolitis
Bronchiolitis · Hypoxemia
Bottom Line
View on ClinicalTrials.gov: NCT02094664 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Jan 2018
Primary outcome: Primary: Change in Respiratory Distress Assessment Instrument (RDAI) From Baseline. — 4.69; 2.69; 4.27; 3 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Heated and humidified oxygen (Device)
- Age
- Pediatric
- Sex
- All
- Sponsor
- UCSF Benioff Children's Hospital Oakland
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Respiratory Distress Assessment Instrument (RDAI) From Baseline. |
4.69; 2.69; 4.27; 3; 4.33; 3.44 | — |
| PRIMARY Change in Respiratory Rate (RR) From Baseline |
45.44; 48.19; 44.81; 45.81; 45.73; 47.25 | — |
| SECONDARY Length of Hospital Stay |
4.44; 4.56 | — |
| SECONDARY Duration of O2 Use |
60.02; 72.11 | — |
Summary
The purpose of this study is to compare heat and humidified oxygen with cold and dry oxygen in children with bronchiolitis.
The hypotheses are that heating and humidifying inspired low flow supplemental oxygen will optimize mucociliary function thereby, 1) improve oxygenation, 2) decrease work of breathing, and 3) decrease length of hospital stay.
Eligibility Criteria
Inclusion Criteria
- Ages ≤24 months of age
- Physician diagnosed bronchiolitis
- Admitted to pediatric floor
- Supplemental oxygen requirement, <4 L/min, for hypoxemia, oxygen saturation <92% in room air
Exclusion Criteria
- Prematurity, born <37 weeks gestational age
- Admitted to pediatric intensive care unit for medical indication
- Requirement of heated, humidified high flow system
- Chronic lung disease (such as bronchopulmonary dysplasia, cystic fibrosis, primary ciliary dyskinesia, tracheostomy status, baseline oxygen requirement)
- Neuromuscular disorders
- Chromosomal defects
- Metabolic disorders
- Immunodeficiency
- Unrepaired cardiac abnormalities
Data sourced from ClinicalTrials.gov (NCT02094664). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.