Heated Humidified Oxygen Compared to Dry Oxygen Therapy in Children With Bronchiolitis
This trial is active, not recruiting.
|Treatment||heated and humidified oxygen|
|Sponsor||Children's Hospital & Research Center Oakland|
|Start date||January 2014|
|End date||April 2015|
|Trial size||30 participants|
|Trial identifier||NCT02094664, 2013-066|
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.
|Intervention model||parallel assignment|
Heated and humified oxygen
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
Male or female participants up to 24 months old.
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
|Official title||HHOT AIR Study (a Pilot Study): Heated Humidified Oxygen Therapy Compared to Standard Dry Oxygen: An Assessment in Infants With bRonchiolitis|
|Principal investigator||Diana Chen, M.D.|
|Description||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.|
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