Clinical trial NCT02094664: Heated Humidified Oxygen Compared to Dry Oxygen Therapy in Children With Bronchiolitis
Official title: HHOT AIR Study (a Pilot Study): Heated Humidified Oxygen Therapy Compared to Standard Dry Oxygen: An Assessment in Infants With bRonchiolitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchiolitis
Hypoxemia
Keywords: Heat
Humidification
Oxygen
Lead sponsor: UCSF Benioff Children's Hospital Oakland
Sponsor class: OTHER
First posted: 2014-03-24
Enrollment: 32
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: Change in Respiratory Distress Assessment Instrument (RDAI) From Baseline.
timeFrame: Baseline, Hour 1, Hour 4, Hour 8, and Hour 12
measure: Change in Respiratory Rate (RR) From Baseline
timeFrame: Baseline, Hour 1, Hour 4, Hour 8, and Hour 12
Secondary outcomes:
measure: Length of Hospital Stay
timeFrame: Subjects will be followed for the duration of hospital stay until discharge
measure: Duration of O2 Use
timeFrame: Subjects will be followed for the duration of oxygen requirement until oxygen discontinued
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Children's Hospital and Research Center Oakland
state: California
Study officials:
affiliation: UCSF Benioff Children's Hospital Oakland
name: Diana Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
References: