BronchiolitisPhase 4NCT00673946
Impact of Oximetry on Hospitalization in Acute Bronchiolitis
A Phase 4 study testing True saturation values displayed and Altered saturation values displayed. in people with Bronchiolitis, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
To determine, in previously healthy infants 6 weeks to 12 months of age, diagnosed with acute bronchiolitis and monitored by hourly oximetry, if the probability of hospitalization within 72 hours of arrival in those whose oxygen saturation display is manipulated 3 percentage points above the true measurements is… Read more about this study
- Who is it for?
- Ages 6 weeks to 12 months
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- True saturation values displayed and Altered saturation values displayed.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 213 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2008to May 2013
- Phase
- Phase 4
- 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 6 weeks to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Acute bronchiolitis
- Age 4 weeks to 12 months
- Baseline Respiratory Disease Assessment Instrument (RDAI) ≥ 3 points
- Informed consent
- Availability of a telephone
Who cannot join
- Pre-existing pulmonary or cardiac distress, neuromuscular disease, congenital or acquired airway anomalies, hemoglobinopathies, or chronic hypoxia
- Severe respiratory distress, defined as the retraction component on the RDAI as 8 out of possible 9 points
- True baseline oxygen saturation less than 88% in room air
- Transfers from other institutions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Oximetry on Hospitalization
To determine, in previously healthy infants 6 weeks to 12 months of age, diagnosed with acute bronchiolitis and monitored by hourly oximetry, if the probability of hospitalization within 72 hours of arrival in those whose oxygen saturation display is manipulated 3 percentage points above the true measurements is significantly lower in comparison to those whose monitors display true saturations.
Read the detailed description
This is the first bronchiolitis study to examine the clinical and economic impact of making disposition decision on primarily clinical grounds, while blinding the physicians to oxygen saturations by providing them with either true saturation measurements or those which are 3 percentage points above the true values. Although physiologically insignificant and within the measurement error of the instrument, this difference has been shown to be perceived as clinically relevant and to have a major hypothetical impact on disposition, without any evidence to support this belief.
We hope to find out if children with oxygen saturations above or in the vicinity of the threshold recommended for initiation of oxygen therapy by the AAP can be safely discharged based on their clinical appearance rather than to have their hospitalization dictated by a locally defined number. This study will hopefully provide much needed evidence necessary to help us interpret the oximetry results more meaningful which may in turn lead to fewer hospitalizations, shorter length of hospital stay and lower health care costs.
- Conditions
- Bronchiolitis
- Being tested
- True saturation values displayed, Altered saturation values displayed.
- Keywords
- bronchiolitis, hospitalization, oximetry, pediatrics
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
True saturation values displayedOther
Physicians will be presented with real saturations.
Altered saturation values displayed.Other
Physicians will be presented with saturation measurements three percentage points above the true values.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | In this arm, patients are monitored with oximeters displaying true saturation values Receives: Other: True saturation values displayed |
| 2 | Experimental | In this arm, patients are monitored with oximeters with displayed saturations 3 percentage points above true values Receives: Other: Altered saturation values displayed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalization for bronchiolitis
Measured: 72 hours from start of study
Secondary outcomes (4)
The proportions of infants receiving supplemental oxygen in the ED
Measured: 72 hours from start the study
Length of stay in the ED (from the time of arrival to the disposition decision)
Measured: Determined by outcome measure
Proportions of infants with unscheduled medical visits for bronchiolitis symptoms to any medical facility
Measured: 72 hours from start of study.
Proportion of the ED staff/fellows in "strong agreement" or "agreement" with discharge
Measured: 0, 60, 120, 180, 240, 300, and 360 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2008 (estimated)
- Study startMar 2008
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suzanne Schuh, The Hospital for Sick Children
- Investigators
- Suzanne Schuh, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00673946
- Sponsor's protocol ID
- 1000011675
- Status last verified
- Dec 2013
- First submitted
- 5 May 2008
- Last updated
- 9 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Schuh S, Freedman S, Coates A, Allen U, Parkin PC, Stephens D, Ungar W, DaSilva Z, Willan AR. Effect of oximetry on hospitalization in bronchiolitis: a randomized clinical trial. JAMA. 2014 Aug 20;312(7):712-8. doi: 10.1001/jama.2014.8637.
PubMed 25138332
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Oximetry on Hospitalization
- ClinicalTrials.gov ID
- NCT00673946
- Acronym / sponsor ID
- 1000011675
- Conditions
- Bronchiolitis
- Keywords
- bronchiolitis, hospitalization, oximetry, pediatrics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 7 May 2008 (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.
To determine, in previously healthy infants 6 weeks to 12 months of age, diagnosed with acute bronchiolitis and monitored by hourly oximetry, if the probability of hospitalization within 72 hours of arrival in those whose oxygen saturation display is manipulated 3 percentage points above the true measurements is significantly lower in comparison to those whose monitors display true saturations.
Detailed description
This is the first bronchiolitis study to examine the clinical and economic impact of making disposition decision on primarily clinical grounds, while blinding the physicians to oxygen saturations by providing them with either true saturation measurements or those which are 3 percentage points above the true values. Although physiologically insignificant and within the measurement error of the instrument, this difference has been shown to be perceived as clinically relevant and to have a major hypothetical impact on disposition, without any evidence to support this belief.
We hope to find out if children with oxygen saturations above or in the vicinity of the threshold recommended for initiation of oxygen therapy by the AAP can be safely discharged based on their clinical appearance rather than to have their hospitalization dictated by a locally defined number. This study will hopefully provide much needed evidence necessary to help us interpret the oximetry results more meaningful which may in turn lead to fewer hospitalizations, shorter length of hospital stay and lower health care costs.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: True saturation values displayedIn this arm, patients are monitored with oximeters displaying true saturation values |
| 2 | Experimental | Other: Altered saturation values displayed.In this arm, patients are monitored with oximeters with displayed saturations 3 percentage points above true values |
Who may qualify
- Ages
- 6 weeks to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Acute bronchiolitis
- Age 4 weeks to 12 months
- Baseline Respiratory Disease Assessment Instrument (RDAI) ≥ 3 points
- Informed consent
- Availability of a telephone
Key exclusion criteria (4 listed)
- Pre-existing pulmonary or cardiac distress, neuromuscular disease, congenital or acquired airway anomalies, hemoglobinopathies, or chronic hypoxia
- Severe respiratory distress, defined as the retraction component on the RDAI as 8 out of possible 9 points
- True baseline oxygen saturation less than 88% in room air
- Transfers from other institutions
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 |
|---|---|---|
| True saturation values displayedPhysicians will be presented with real saturations. | Other | 1 |
| Altered saturation values displayed.Physicians will be presented with saturation measurements three percentage points above the true values. | Other | 2 |
Primary outcome
Hospitalization for bronchiolitis
Time frame: 72 hours from start of study
4 secondary outcomes
The proportions of infants receiving supplemental oxygen in the ED
Time frame: 72 hours from start the study
Length of stay in the ED (from the time of arrival to the disposition decision)
Time frame: Determined by outcome measure
Proportions of infants with unscheduled medical visits for bronchiolitis symptoms to any medical facility
Time frame: 72 hours from start of study.
Proportion of the ED staff/fellows in "strong agreement" or "agreement" with discharge
Time frame: 0, 60, 120, 180, 240, 300, and 360 minutes
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 9 Dec 2013.
- Derived from this study: PubMed 25138332Schuh S, Freedman S, Coates A, Allen U, Parkin PC, Stephens D, Ungar W, DaSilva Z, Willan AR. Effect of oximetry on hospitalization in bronchiolitis: a randomized clinical trial. JAMA. 2014 Aug 20;312(7):712-8. doi: 10.1001/jama.2014.8637.
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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.
Suzanne Schuh, MD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing True saturation values displayed and Altered saturation values displayed. in people with Bronchiolitis, run by The Hospital for Sick Children at 1 site 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 9 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Hospitalization for bronchiolitis (time frame: 72 hours from start of study). 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 NCT00673946, which also lists 1 linked publication.
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 9 Dec 2013.