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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Bronchiolitis Hypoxemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard oxygen via nasal cannula

Standard therapy

Group Type NO_INTERVENTION

No interventions assigned to this group

Heated and humidified oxygen

Heated and humified oxygen

Group Type ACTIVE_COMPARATOR

Heated and humidified oxygen

Intervention Type DEVICE

Interventions

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Heated and humidified oxygen

Intervention Type DEVICE

Eligibility Criteria

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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

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No