Heated Humidified Oxygen Compared to Dry Oxygen Therapy in Children With Bronchiolitis
Recruitment status was: Active, not recruiting
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||HHOT AIR Study (a Pilot Study): Heated Humidified Oxygen Therapy Compared to Standard Dry Oxygen: An Assessment in Infants With bRonchiolitis|
- Change in Respiratory Distress Assessment Instrument (RDAI) and respiratory rate (RR) from baseline. [ Time Frame: Study specific ]
- Length of hospital stay [ Time Frame: Subjects will be followed for the duration of hospital stay ]
- Duration of supplemental oxygen requirement [ Time Frame: Subjects will be followed for the duration of oxygen requirement ]
|Study Start Date:||January 2014|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
No Intervention: Standard oxygen via nasal cannula
Active Comparator: Heated and humidified oxygen
Heated and humified oxygen
|Device: Heated and humidified oxygen|
Bronchiolitis is the leading cause of acute respiratory illness and hospitalization in infants and young children. The mainstay of treatment is supportive care, which includes frequent nasal suctioning, intravenous fluid hydration, and supplemental oxygen for hypoxemia.
The airways normally heat and humidify inspired ambient air to core temperature amd 100% relative humidity at the carina. This environment, at core temperature, allows for optimal mucociliary clearance. Supplemental oxygen delivered via wall source is cold and dry, and does not reach core temperature and 100% humidity until some point distal to the carina, past the main bronchi. This presses on the lower respiratory tract to assist in heat and moisture exchange and thus decrease ciliary function. This, in combination with bronchiolitis, can impair mucociliary clearance.
Specific aim 1: Determine the effect of heated and humidified oxygen therapy on clinical improvement in children with bronchiolitis, based on Respiratory Distress Assessment Instrument (RDAI) and respiratory rate (RR).
Specific aim 2: Determine the effect of heated and humidified oxygen therapy on length of hospital stay and duration of supplemental oxygen requirement in children with bronchiolitis.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02094664
|United States, California|
|Children's Hospital and Research Center Oakland|
|Oakland, California, United States, 94609|
|Principal Investigator:||Diana Chen, M.D.||Children's Hospital & Research Center Oakland|