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

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

• Status: Completed
• Conditions: Bronchiolitis; Hypoxemia
• Intervention / Treatment: Device: Heated and humidified oxygen

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Oakland, California, United States, 94609
      • Children's Hospital and Research Center Oakland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard oxygen via nasal cannula; Standard therapy
Active Comparator: Heated and humidified oxygen; Heated and humified oxygen	Device: Heated and humidified oxygen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Respiratory Distress Assessment Instrument (RDAI) From Baseline.	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.	Baseline, Hour 1, Hour 4, Hour 8, and Hour 12
Change in Respiratory Rate (RR) From Baseline	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.	Baseline, Hour 1, Hour 4, Hour 8, and Hour 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Hospital Stay	Length of hospital stay is measured in days and counted from day of admission to day of discharge.	Subjects will be followed for the duration of hospital stay until discharge
Duration of O2 Use	Duration on supplemental O2 was measured in hours.	Subjects will be followed for the duration of oxygen requirement until oxygen discontinued

Collaborators and Investigators

• Sponsor: UCSF Benioff Children's Hospital Oakland
• Investigators: Principal Investigator: Diana Chen, M.D., UCSF Benioff Children's Hospital Oakland

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: March 18, 2014
• First Submitted That Met QC Criteria: March 19, 2014
• First Posted (Estimate): March 24, 2014

Study Record Updates

• Last Update Posted (Actual): January 8, 2018
• Last Update Submitted That Met QC Criteria: January 5, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Heat; Oxygen; Humidification
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Signs and Symptoms, Respiratory; Lung Diseases, Obstructive; Bronchitis; Hypoxia; Bronchiolitis
• Other Study ID Numbers: 2013-066