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Completed

NCT Number: NCT02094664

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.

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Key information

Conditions

Bronchiolitis Bronchial Diseases Bronchitis Hypoxemia Hypoxia Infections Lung Diseases Lung Diseases, Obstructive Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Signs and Symptoms, Respiratory

Age range

Up to 24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital and Research Center Oakland

Oakland, California, 94609, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Heated and humidified oxygen

Device

Primary outcomes

  1. Change in Respiratory Distress Assessment Instrument (RDAI) From Baseline.

    Time frame: 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.

  2. Change in Respiratory Rate (RR) From Baseline

    Time frame: Baseline, 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 outcomes

  1. Length of Hospital Stay

    Time frame: Subjects 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.

  2. Duration of O2 Use

    Time frame: Subjects will be followed for the duration of oxygen requirement until oxygen discontinued

    Duration on supplemental O2 was measured in hours.

Sponsors and collaborators

Lead sponsor

UCSF Benioff Children's Hospital Oakland

Other

Registry information

Official study title

HHOT AIR Study (a Pilot Study): Heated Humidified Oxygen Therapy Compared to Standard Dry Oxygen: An Assessment in Infants With bRonchiolitis

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 24, 2014
Registry last updated
Jan 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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