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

Primary Purpose

Bronchiolitis

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Intermittent oxygen monitoring
Continuous oxygen monitoring
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Bronchiolitis focused on measuring Bronchiolitis, Length of stay, Pilot Projects, Oxygen saturation monitoring

Eligibility Criteria

6 Weeks - 24 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital for Sick Children

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Continuous oxygen monitoring

Intermittent oxygen monitoring

Arm Description

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.

Outcomes

Primary Outcome Measures

Length of hospital stay

Secondary Outcome Measures

Full Information

First Posted
April 4, 2012
Last Updated
July 23, 2016
Sponsor
The Hospital for Sick Children
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1. Study Identification

Unique Protocol Identification Number
NCT01646606
Brief Title
Monitoring OXYgen in Infants Hospitalized With Bronchiolitis: A Best Practices Trial (The MOXY Trial)
Official Title
Monitoring OXYgen in Infants Hospitalized With Bronchiolitis: A Best Practices Trial (The MOXY Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis
Keywords
Bronchiolitis, Length of stay, Pilot Projects, Oxygen saturation monitoring

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Continuous oxygen monitoring
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Intermittent oxygen monitoring
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Intermittent oxygen monitoring
Intervention Description
Oxygen saturation and vital signs will be measured intermittently at a frequency of every 4 hours by the bedside nurse through the child's hospital stay until discharge. The nurse will attach the probe to the electrical cord which is connected to the monitor. For each measurement, the duration of monitoring will be until a steady wave form is present on the oxygen saturation monitor, indicating a reliable measurement (consistent with current standard of practice). The nurse will document the maximum and minimum reading during the period. The nurse will detach the probe from the electrical cord, leaving the probe attached to the child. Hence, the child's probe will be attached to the electrical cord intermittently as well.
Intervention Type
Procedure
Intervention Name(s)
Continuous oxygen monitoring
Intervention Description
Oxygen saturation will be measured continuously through the child's hospital stay until discharge. Every 4 hours the nurse will complete and document a set of vital sign measurements, including oxygen saturation level, in keeping with current clinical practice. The reading will be displayed on the bedside monitor in the participants' room. At the completion of vital signs measurement, the nurse will not detach the electrical cord from the probe. Hence, the child's probe will be attached to the electrical cord continuously as well.
Primary Outcome Measure Information:
Title
Length of hospital stay
Time Frame
Admission - Discharge (up to 2 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Weeks
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanjay Mahant, MD, MSc
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada

12. IPD Sharing Statement

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

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