Heated Humidified Oxygen Compared to Dry Oxygen Therapy in Children With Bronchiolitis
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: None (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 ]The RDAI is a validated clinical scoring system to assess respiratory distress and has been used in several bronchiolitis studies. he RDAI is based on two variables, wheezing and retractions, in which points are applied to each to give a score ranging from 0 to 17. The higher the total score, the worse the subject was clinically. Respiratory rate was measured by counting respirations for one minute. Oxygen saturation was determined by the value on pulse oximetry with appropriate waveform.
- Length of hospital stay [ Time Frame: Subjects will be followed for the duration of hospital stay ]Length of hospital stay is measured in days and counted from day of admission to day of discharge.
- Duration of supplemental oxygen requirement [ Time Frame: Subjects will be followed for the duration of oxygen requirement ]Duration was measured in hours.
|Study Start Date:||January 2014|
|Study Completion Date:||June 2015|
|Primary Completion Date:||June 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|