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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Diana Chen, Children's Hospital & Research Center Oakland
ClinicalTrials.gov Identifier:
NCT02094664
First received: March 18, 2014
Last updated: June 16, 2017
Last verified: June 2017
  Purpose

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 Intervention
Bronchiolitis Hypoxemia Device: Heated and humidified oxygen

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: HHOT AIR Study (a Pilot Study): Heated Humidified Oxygen Therapy Compared to Standard Dry Oxygen: An Assessment in Infants With bRonchiolitis

Resource links provided by NLM:


Further study details as provided by Diana Chen, Children's Hospital & Research Center Oakland:

Primary Outcome Measures:
  • Change in Respiratory Distress Assessment Instrument (RDAI) and respiratory rate (RR) from baseline. [ Time Frame: Study specific ]
    The RDAI is a validated clinical scoring system to assess respiratory distress and has been used in several bronchiolitis studies. he 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. Respiratory rate was measured by counting respirations for one minute. Oxygen saturation was determined by the value on pulse oximetry with appropriate waveform.


Secondary Outcome Measures:
  • Length of hospital stay [ Time Frame: Subjects will be followed for the duration of hospital stay ]
    Length of hospital stay is measured in days and counted from day of admission to day of discharge.

  • Duration of supplemental oxygen requirement [ Time Frame: Subjects will be followed for the duration of oxygen requirement ]
    Duration was measured in hours.


Enrollment: 32
Study Start Date: January 2014
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard oxygen via nasal cannula
Standard therapy
Active Comparator: Heated and humidified oxygen
Heated and humified oxygen
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.

  Eligibility

Ages Eligible for Study:   up to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02094664

Locations
United States, California
Children's Hospital and Research Center Oakland
Oakland, California, United States, 94609
Sponsors and Collaborators
Children's Hospital & Research Center Oakland
Investigators
Principal Investigator: Diana Chen, M.D. Children's Hospital & Research Center Oakland
  More Information

Responsible Party: Diana Chen, Pediatric Pulmonary Fellow, Children's Hospital & Research Center Oakland
ClinicalTrials.gov Identifier: NCT02094664     History of Changes
Other Study ID Numbers: 2013-066
Study First Received: March 18, 2014
Last Updated: June 16, 2017

Keywords provided by Diana Chen, Children's Hospital & Research Center Oakland:
Heat
Humidification
Oxygen

Additional relevant MeSH terms:
Bronchiolitis
Anoxia
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on August 22, 2017