Monitoring OXYgen in Infants Hospitalized With Bronchiolitis: A Best Practices Trial (The MOXY Trial)

Phase 1

Completed

• Conditions: Bronchiolitis
• Interventions: Procedure: Continuous oxygen monitoring; Procedure: Intermittent oxygen monitoring

• Registration Number: NCT01646606
• Lead Sponsor: The Hospital for Sick Children

Brief Summary

In infants hospitalized with bronchiolitis, a common infection in the lungs caused by a virus, it is uncertain on how to best monitor their oxygen levels. It is common to place a probe on infants hands or legs to monitor oxygen levels. The probe can be used to monitor oxygen levels all the time (continuous oxygen monitoring) or just every 4-6 hours (intermittent oxygen monitoring). There is reason to believe that placing children with bronchiolitis on continuous monitoring might result in children staying longer in hospital than needed. This is a research study that is aiming to provide data to plan a larger research study to answer the question of whether intermittent oxygen monitoring is better than continuous oxygen monitoring. This study is part of a larger initiative to determine the best way to care for children with bronchiolitis, including making sure that children do not stay in hospital longer than needed.

Parents will be asked to participate in this research study if their child is hospitalized with bronchiolitis and has been stable for at least 6 hours, meaning that he/she is not having more trouble breathing or does not require more supplemental oxygen. If they agree participate, the child will have one of the two oxygen monitoring strategies: intermittent or continuous monitoring. Each child will have an equal chance of getting one or the other of these two monitoring strategies.

The study team will review the children's charts to determine the number of tests ordered, the need for intensive care unit help or admissions, the number of blood tests and chest x-rays the treating doctors ordered, and the length of hospital stay. Parents will be contacted about 4-5 days after discharge to ask if there were any unscheduled visits to doctors or emergency rooms after discharge. The investigators will the parents to fill out a scale twice a day asking how well their child is feeding. The investigators will also them to rate their anxiety level once a day.

The information from this study will help plan and support an application for external funding. The results of a larger study could potentially decrease unnecessary monitoring, oxygen supplementation, and hospital stay and thereby improve quality of care with large cost savings. A reduction in length of hospital stay for this common hospital condition would also reduce the burden of hospitalization to families and reduce the risks associated with harm in the hospital setting such as infection and medical error.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-04-04
• Study First Submitted QC: 2012-07-17
• Study First Posted: 2012-07-20
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-23
• Last Update Posted: 2016-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• First episode of acute bronchiolitis.
• Clinical diagnosis of bronchiolitis as defined by the American Academic of Pediatrics Clinical Practice Guideline: Diagnosis and Management of Bronchiolitis as a constellation of clinical findings on history and physical exam; clinical findings include 1) a preceding viral upper respiratory infection; 2) presence of wheeze on chest auscultation; 3) increased respiratory effort
• Clinical status stable for 6 hours as defined by 1) stable or decreasing requirement for supplemental oxygen AND a stable or decreasing respiratory rate (within 10 breaths per minute) on at least two measurements; 2) respiratory rate < 70 breaths/minute; 3) oxygen supplementation < 40% FiO2 or < 2 L/min by nasal prongs; and 4) heart rate < 180 beats per minute
• Availability of home telephone or mobile cell phone to contact the participant's parent/guardian after discharge from hospital

Exclusion Criteria

• Preexisting chronic medical condition which includes the following: 1) congenital heart disease that is cyanotic, hemodynamically significant requiring diuretics, and/or with pulmonary hypertension; 2) chronic lung disease with home oxygen requirement and/or pulmonary hypertension; 3)neuromuscular disease; 4) immunodeficiency; or 5) hemoglobinopathy
• Premature birth (< 36 weeks)
• History of apnea on current admission
• Receiving morphine infusions
• Weight < 4kg

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous oxygen monitoring	Continuous oxygen monitoring	Oxygen saturation will be measured continuously through the child's hospital stay until discharge. Vital signs will be measured at a frequency determined by the responsible physician (as is current practice). The reading will be displayed on the bedside monitor in the participants' room.
Intermittent oxygen monitoring	Intermittent oxygen monitoring	-

Primary Outcome Measures

Name	Time	Method
Length of hospital stay	Admission - Discharge (up to 2 weeks)

Trial Locations

Locations (1)

Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada