BronchiolitisNCT02947204
Oxygen Saturation Monitoring in Bronchiolitis
A study testing Intermittent oxygen monitoring and Continuous oxygen monitoring in people with Bronchiolitis, run by The Hospital for Sick Children at 6 sites in Canada.
Trial summary
The investigators will conduct a study around the best way to monitor infants hospitalized with bronchiolitis, the most common lung infection and a leading reason for hospitalization in infants. Infants with bronchiolitis have breathing difficulties and are provided supplemental oxygen if their oxygen levels are low. Read more about this study
- Who is it for?
- Ages 4 weeks to 24 months
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- Intermittent oxygen monitoring and Continuous oxygen monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 219 participants
- Where
- 6 sitesCanada
- Study dates
- Nov 2016to May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 weeks to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinical diagnosis of bronchiolitis as determined by the attending physician.
- First episode of acute bronchiolitis.
- Age: 4 weeks to 24 months.
- Clinical status stable for 6 hours
- Parent consent
Who cannot join
- Known risk factors for clinical deterioration including chronic medical condition; premature birth (<35weeks), history of apnea, weight < 4kg, receiving morphine
- Patient on heated high flow oxygen at enrolment
- ICU admission on current admission
- No telephone available
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites
McMaster Children's Hospital
Hamilton, Ontario, L8N 2Z5
Trillium Health Partners (Credit Valley Site)
Mississauga, Ontario, L5B 1B8
Lakeridge Health Oshawa
Oshawa, Ontario, L1G 2B9
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1
North York General Hospital
Toronto, Ontario, M2K 1E1
Hospital for Sick Children
Toronto, Ontario, M5G 1X8
About this study
Official title: Intermittent vs. Continuous Oxygen Saturation Monitoring in Infants Hospitalized for Bronchiolitis: A Randomized Controlled Trial
The investigators will conduct a study around the best way to monitor infants hospitalized with bronchiolitis, the most common lung infection and a leading reason for hospitalization in infants. Infants with bronchiolitis have breathing difficulties and are provided supplemental oxygen if their oxygen levels are low. However, there is uncertainty regarding how to best monitor oxygen levels. A probe placed on the hand or foot can be used to monitor oxygen levels all the time (continuous oxygen monitoring) or just every 4-6 hours (intermittent oxygen monitoring). Research has suggested that placing infants with bronchiolitis on continuous monitoring results in unnecessary use of oxygen and infants staying longer in hospital. However, due to the lack of high quality research, its unclear which strategy is best and practice varies. The objective of this study is to conduct high quality research across hospitals to determine whether intermittent compared to continuous oxygen monitoring will reduce the length of hospital stay in infants hospitalized with bronchiolitis. The investigators will also compare safety and cost. The results of this study will inform bronchiolitis practice standards and the best use of health care resources.
Read the detailed description
BACKGROUND This research protocol focuses on bronchiolitis, a leading cause of infant hospitalization and cumulative expense for the health care system. Supportive management, such as oxygen supplementation and monitoring, is the major focus of care, as active medical treatment is not effective. Oxygen saturation monitoring may be performed on an intermittent (e.g. every 4-6hrs) or continuous basis for stable infants hospitalized with bronchiolitis. Observational studies find that the use of continuous monitoring is associated with overuse of supplemental oxygen and longer hospital stay. Based on this low quality evidence, practice guidelines state that clinicians may choose not to use continuous monitoring and practice variation exists due to a lack of RCTs.
SPECIFIC AIMS Primary: To determine if intermittent vs continuous oxygen saturation monitoring will reduce length of hospital stay in infants with bronchiolitis. Secondary: To determine differences in other outcomes - effectiveness, safety, acceptability, and cost.
METHODOLOGY Design: multi-centre, pragmatic, parallel group, 1:1, two arm superiority RCT. Population: Previously healthy infants (4 weeks-2 years) hospitalized with bronchiolitis who are clinically stable, will be recruited from children's and community hospitals in Ontario, Canada.
Interventions: Randomization to intermittent (every 4hrs) or continuous oxygen saturation monitoring. In keeping with local and national clinical practice guidelines, an acceptable oxygen saturation target of ≥ 90% will be used for both groups.
- Conditions
- Bronchiolitis
- Being tested
- Intermittent oxygen monitoring, Continuous oxygen monitoring
- Keywords
- Bronchiolitis, Length of Hospital Stay, Clinical Trial, Oxygen Saturation Monitoring
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent oxygen monitoringOther
Also called Intermittent
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. Vital signs will be completed every 4 hours.
Continuous oxygen monitoringOther
Also called Continuous
Oxygen saturation will be measured continuously through the child's hospital stay until discharge. Vital signs will be completed every 4 hours.
| Study group | Role | What they receive |
|---|---|---|
| Continuous oxygen monitoring | Active comparator | Oxygen saturation will be measured continuously through the child's hospital stay until discharge. Receives: Other: Continuous oxygen monitoring |
| Intermittent oxygen monitoring | Experimental | Oxygen saturation will be measured intermittently, every 4 hours, through the child's hospital stay until discharge. Receives: Other: Intermittent oxygen monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay from randomization on the inpatient unit to discharge from hospital
Measured: 1 month
Secondary outcomes (12)
Duration of oxygen supplementation from randomization to discontinuation of supplementation
Measured: 1 month
Number of medical interventions performed from time of randomization to hospital discharge
Measured: 1 month
Time from randomization to meeting hospital discharge criteria
Measured: 1 month
Length of hospital stay from inpatient unit admission to hospital discharge
Measured: 1 month
Parent anxiety
Parents will rate their level of anxiety at the current time (state anxiety) and generally (trait anxiety) from the adult State Trait Anxiety Inventory questionnaire during the hospital stay.
Measured: 1 month
Number of parent work days missed from randomization to 15 days after discharge
Measured: 15 days after discharge
Nursing satisfaction
The attending nurse will be asked to complete a 10 mm visual analogue scale (VAS) to measure their satisfaction with the quality of monitoring.
Measured: 1 month
PICU admission after randomization
Measured: 1 month
PICU consultation after admission
Measured: 1 month
Unscheduled return to care within 15 days of discharge
Measured: 15 days after discharge
Mortality
Measured: 15 days after discharge.
Cost-Effectiveness
Cost-effectiveness will be measured by the incremental cost-effectiveness ratio (ICER), a ratio defined by the incremental difference in costs between treatment arms and the incremental difference in length of stay.
Measured: 15 days after discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2016 (estimated)
- Study startNov 2016
- Primary completionMay 2019
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for BronchiolitisStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Children's Hospital of Eastern Ontario
- Responsible party
- Principal investigator, Sanjay Mahant, The Hospital for Sick Children
- Investigators
- Sanjay Mahant, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02947204
- Sponsor's protocol ID
- 1000054699
- Status last verified
- Mar 2020
- First submitted
- 20 Oct 2016
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Mahant S, Wahi G, Bayliss A, Giglia L, Kanani R, Pound CM, Sakran M, Kozlowski N, Breen-Reid K, Arafeh D, Moretti ME, Agarwal A, Barrowman N, Willan AR, Schuh S, Parkin PC; Canadian Paediatric Inpatient Research Network (PIRN). Intermittent vs Continuous Pulse Oximetry in Hospitalized Infants With Stabilized Bronchiolitis: A Randomized Clinical Trial. JAMA Pediatr. 2021 May 1;175(5):466-474. doi: 10.1001/jamapediatrics.2020.6141.
PubMed 33646286Mahant S, Wahi G, Giglia L, Pound C, Kanani R, Bayliss A, Roy M, Sakran M, Kozlowski N, Breen-Reid K, Lavigne M, Premji L, Moretti ME, Willan AR, Schuh S, Parkin PC. Intermittent versus continuous oxygen saturation monitoring for infants hospitalised with bronchiolitis: study protocol for a pragmatic randomised controlled trial. BMJ Open. 2018 Apr 20;8(4):e022707. doi: 10.1136/bmjopen-2018-022707.
PubMed 29678995
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent vs. Continuous Oxygen Saturation Monitoring in Infants Hospitalized for Bronchiolitis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02947204
- Acronym / sponsor ID
- 1000054699
- Conditions
- Bronchiolitis
- Keywords
- Bronchiolitis, Length of Hospital Stay, Clinical Trial, Oxygen Saturation Monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Children's Hospital of Eastern Ontario
- Study start
- Nov 2016 (actual)
- Primary completion
- May 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 27 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will conduct a study around the best way to monitor infants hospitalized with bronchiolitis, the most common lung infection and a leading reason for hospitalization in infants. Infants with bronchiolitis have breathing difficulties and are provided supplemental oxygen if their oxygen levels are low. However, there is uncertainty regarding how to best monitor oxygen levels. A probe placed on the hand or foot can be used to monitor oxygen levels all the time (continuous oxygen monitoring) or just every 4-6 hours (intermittent oxygen monitoring). Research has suggested that placing infants with bronchiolitis on continuous monitoring results in unnecessary use of oxygen and infants staying longer in hospital. However, due to the lack of high quality research, its unclear which strategy is best and practice varies. The objective of this study is to conduct high quality research across hospitals to determine whether intermittent compared to continuous oxygen monitoring will reduce the length of hospital stay in infants hospitalized with bronchiolitis. The investigators will also compare safety and cost. The results of this study will inform bronchiolitis practice standards and the best use of health care resources.
Detailed description
BACKGROUND This research protocol focuses on bronchiolitis, a leading cause of infant hospitalization and cumulative expense for the health care system. Supportive management, such as oxygen supplementation and monitoring, is the major focus of care, as active medical treatment is not effective. Oxygen saturation monitoring may be performed on an intermittent (e.g. every 4-6hrs) or continuous basis for stable infants hospitalized with bronchiolitis. Observational studies find that the use of continuous monitoring is associated with overuse of supplemental oxygen and longer hospital stay. Based on this low quality evidence, practice guidelines state that clinicians may choose not to use continuous monitoring and practice variation exists due to a lack of RCTs.
SPECIFIC AIMS Primary: To determine if intermittent vs continuous oxygen saturation monitoring will reduce length of hospital stay in infants with bronchiolitis. Secondary: To determine differences in other outcomes - effectiveness, safety, acceptability, and cost.
METHODOLOGY Design: multi-centre, pragmatic, parallel group, 1:1, two arm superiority RCT. Population: Previously healthy infants (4 weeks-2 years) hospitalized with bronchiolitis who are clinically stable, will be recruited from children's and community hospitals in Ontario, Canada.
Interventions: Randomization to intermittent (every 4hrs) or continuous oxygen saturation monitoring. In keeping with local and national clinical practice guidelines, an acceptable oxygen saturation target of ≥ 90% will be used for both groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous oxygen monitoring | Active comparator | Other: Continuous oxygen monitoringOxygen saturation will be measured continuously through the child's hospital stay until discharge. |
| Intermittent oxygen monitoring | Experimental | Other: Intermittent oxygen monitoringOxygen saturation will be measured intermittently, every 4 hours, through the child's hospital stay until discharge. |
Who may qualify
- Ages
- 4 weeks to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Clinical diagnosis of bronchiolitis as determined by the attending physician.
- First episode of acute bronchiolitis.
- Age: 4 weeks to 24 months.
- Clinical status stable for 6 hours
- Parent consent
Key exclusion criteria (4 listed)
- Known risk factors for clinical deterioration including chronic medical condition; premature birth (<35weeks), history of apnea, weight < 4kg, receiving morphine
- Patient on heated high flow oxygen at enrolment
- ICU admission on current admission
- No telephone available
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent oxygen monitoringAlso: IntermittentOxygen 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. Vital signs will be completed every 4 hours. | Other | Intermittent oxygen monitoring |
| Continuous oxygen monitoringAlso: ContinuousOxygen saturation will be measured continuously through the child's hospital stay until discharge. Vital signs will be completed every 4 hours. | Other | Continuous oxygen monitoring |
Primary outcome
Length of hospital stay from randomization on the inpatient unit to discharge from hospital
Time frame: 1 month
12 secondary outcomes
Duration of oxygen supplementation from randomization to discontinuation of supplementation
Time frame: 1 month
Number of medical interventions performed from time of randomization to hospital discharge
Time frame: 1 month
Time from randomization to meeting hospital discharge criteria
Time frame: 1 month
Length of hospital stay from inpatient unit admission to hospital discharge
Time frame: 1 month
Parent anxiety
Time frame: 1 month
Number of parent work days missed from randomization to 15 days after discharge
Time frame: 15 days after discharge
Nursing satisfaction
Time frame: 1 month
PICU admission after randomization
Time frame: 1 month
PICU consultation after admission
Time frame: 1 month
Unscheduled return to care within 15 days of discharge
Time frame: 15 days after discharge
Mortality
Time frame: 15 days after discharge.
Cost-Effectiveness
Time frame: 15 days after discharge.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- Derived from this study: PubMed 33646286Mahant S, Wahi G, Bayliss A, Giglia L, Kanani R, Pound CM, Sakran M, Kozlowski N, Breen-Reid K, Arafeh D, Moretti ME, Agarwal A, Barrowman N, Willan AR, Schuh S, Parkin PC; Canadian Paediatric Inpatient Research Network (PIRN). Intermittent vs Continuous Pulse Oximetry in Hospitalized Infants With Stabilized Bronchiolitis: A Randomized Clinical Trial. JAMA Pediatr. 2021 May 1;175(5):466-474. doi: 10.1001/jamapediatrics.2020.6141.
- Derived from this study: PubMed 29678995Mahant S, Wahi G, Giglia L, Pound C, Kanani R, Bayliss A, Roy M, Sakran M, Kozlowski N, Breen-Reid K, Lavigne M, Premji L, Moretti ME, Willan AR, Schuh S, Parkin PC. Intermittent versus continuous oxygen saturation monitoring for infants hospitalised with bronchiolitis: study protocol for a pragmatic randomised controlled trial. BMJ Open. 2018 Apr 20;8(4):e022707. doi: 10.1136/bmjopen-2018-022707.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanjay Mahant principal investigator
The Hospital for Sick Children
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent oxygen monitoring and Continuous oxygen monitoring in people with Bronchiolitis, run by The Hospital for Sick Children at 6 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay from randomization on the inpatient unit to discharge from hospital (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02947204, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2020.