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Heated Humidified Oxygen Compared to Dry Oxygen Therapy in Children With Bronchiolitis

Not Applicable
Completed
Conditions
Bronchiolitis
Hypoxemia
Interventions
Device: Heated and humidified oxygen
Registration Number
NCT02094664
Lead Sponsor
UCSF Benioff Children's Hospital Oakland
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
32
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Heated and humidified oxygenHeated and humidified oxygenHeated and humified oxygen
Primary Outcome Measures
NameTimeMethod
Change in Respiratory Distress Assessment Instrument (RDAI) From Baseline.Baseline, Hour 1, Hour 4, Hour 8, and Hour 12

The RDAI is a validated clinical scoring system to assess respiratory distress and has been used in several bronchiolitis studies. The 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. Reported are the absolute scores at each time point, for each arm. Baseline scores are reported in the Baseline Module.

Change in Respiratory Rate (RR) From BaselineBaseline, Hour 1, Hour 4, Hour 8, and Hour 12

Respiratory rate was measured by counting respirations for one minute. Reported are the absolute scores at each time point, for each arm. Baseline scores are reported in the Baseline Module.

Secondary Outcome Measures
NameTimeMethod
Length of Hospital StaySubjects will be followed for the duration of hospital stay until discharge

Length of hospital stay is measured in days and counted from day of admission to day of discharge.

Duration of O2 UseSubjects will be followed for the duration of oxygen requirement until oxygen discontinued

Duration on supplemental O2 was measured in hours.

Trial Locations

Locations (1)

Children's Hospital and Research Center Oakland

🇺🇸

Oakland, California, United States

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