Heated Humidified Oxygen Compared to Dry Oxygen Therapy in Children With Bronchiolitis
Primary Purpose
Bronchiolitis, Hypoxemia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Heated and humidified oxygen
Sponsored by
About this trial
This is an interventional treatment trial for Bronchiolitis focused on measuring Heat, Humidification, Oxygen
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
Sites / Locations
- Children's Hospital and Research Center Oakland
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Standard oxygen via nasal cannula
Heated and humidified oxygen
Arm Description
Standard therapy
Heated and humified oxygen
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Length of Hospital Stay
Length of hospital stay is measured in days and counted from day of admission to day of discharge.
Duration of O2 Use
Duration on supplemental O2 was measured in hours.
Full Information
NCT ID
NCT02094664
First Posted
March 18, 2014
Last Updated
January 5, 2018
Sponsor
UCSF Benioff Children's Hospital Oakland
1. Study Identification
Unique Protocol Identification Number
NCT02094664
Brief Title
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
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UCSF Benioff Children's Hospital Oakland
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis, Hypoxemia
Keywords
Heat, Humidification, Oxygen
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard oxygen via nasal cannula
Arm Type
No Intervention
Arm Description
Standard therapy
Arm Title
Heated and humidified oxygen
Arm Type
Active Comparator
Arm Description
Heated and humified oxygen
Intervention Type
Device
Intervention Name(s)
Heated and humidified oxygen
Primary Outcome Measure Information:
Title
Change in Respiratory Distress Assessment Instrument (RDAI) From Baseline.
Description
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.
Time Frame
Baseline, Hour 1, Hour 4, Hour 8, and Hour 12
Title
Change in Respiratory Rate (RR) From Baseline
Description
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.
Time Frame
Baseline, Hour 1, Hour 4, Hour 8, and Hour 12
Secondary Outcome Measure Information:
Title
Length of Hospital Stay
Description
Length of hospital stay is measured in days and counted from day of admission to day of discharge.
Time Frame
Subjects will be followed for the duration of hospital stay until discharge
Title
Duration of O2 Use
Description
Duration on supplemental O2 was measured in hours.
Time Frame
Subjects will be followed for the duration of oxygen requirement until oxygen discontinued
10. Eligibility
Sex
All
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diana Chen, M.D.
Organizational Affiliation
UCSF Benioff Children's Hospital Oakland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital and Research Center Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
12. IPD Sharing Statement
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Heated Humidified Oxygen Compared to Dry Oxygen Therapy in Children With Bronchiolitis
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