Heated Humidified Oxygen Compared to Dry Oxygen Therapy in Children With Bronchiolitis
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|ClinicalTrials.gov Identifier: NCT02094664|
Recruitment Status : Completed
First Posted : March 24, 2014
Results First Posted : January 8, 2018
Last Update Posted : January 8, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Bronchiolitis Hypoxemia||Device: Heated and humidified oxygen||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||HHOT AIR Study (a Pilot Study): Heated Humidified Oxygen Therapy Compared to Standard Dry Oxygen: An Assessment in Infants With bRonchiolitis|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
No Intervention: Standard oxygen via nasal cannula
Active Comparator: Heated and humidified oxygen
Heated and humified oxygen
Device: Heated and humidified oxygen
- 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.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02094664
|United States, California|
|Children's Hospital and Research Center Oakland|
|Oakland, California, United States, 94609|
|Principal Investigator:||Diana Chen, M.D.||Children's Hospital & Research Center Oakland|