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

Bronchiolitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02094664
• Other study ID #: 2013-066
• Status: Completed
• Phase: N/A
• First received: March 18, 2014
• Last updated: January 5, 2018
• Start date: January 2014
• Est. completion date: June 2015

Study information

• Verified date: January 2018
• Source: Children's Hospital & Research Center Oakland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 24 Months

Eligibility

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

Related Conditions & MeSH terms

• Bronchiolitis
• Hypoxemia
• Hypoxia

Intervention

Device:
• Heated and humidified oxygen

Locations

Country	Name	City	State
United States	Children's Hospital and Research Center Oakland	Oakland	California

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital & Research Center Oakland

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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