Obstructive Sleep ApneaNCT03281408
Perioperative Complications and Myocardial Injury Risk in Arthoplasty Patients Suspected of Having Obstructive Sleep Apnea
An observational study of Obstructive Sleep Apnea, run by University of British Columbia at 1 site in Canada.
Trial summary
Obstructive Sleep Apnea (OSA) is a common and under-diagnosed breathing disorder characterized by recurrent partial or complete collapse of the upper airway (tongue, soft palate) during sleep. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 4 Dec 2017to 12 Oct 2018
- Phase
- Observational
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred to the UBC Hospital to have knee/hip arthroplasty surgery.
Who may be able to join
- Patients undergoing elective primary or revision knee/hip replacement surgery.
- Patients with no previous OSA diagnosis (by polysomnography), who score >=5 on STOP-BANG OSA screening.
Who cannot join
- Patients without ability to communicate in English by reading or writing.
- Patients with renal failure.
- Patients on CPAP therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perioperative Obstructive Sleep Apnea Intervention Study
Obstructive Sleep Apnea (OSA) is a common and under-diagnosed breathing disorder characterized by recurrent partial or complete collapse of the upper airway (tongue, soft palate) during sleep. It causes recurrent episodes of asphyxia (suffocation) resulting in fragmented sleep, low blood oxygen levels (hypoxemia), and high carbon dioxide concentrations. Untreated OSA is associated with serious heart/lung and metabolic diseases including strokes, diabetes, and heart attacks.
When a patient with OSA undergoes surgery, the symptoms of OSA are exacerbated afterwards due to the effects of anesthesia and related medications such as those used for pain control. This puts patients at higher risk for complications and necessitates nursing care and monitoring that are resource intensive. In many hospitals, patients with an OSA diagnosis are monitored after surgery in "high acuity" wards where the nurse to patient ratio is higher than usual. These high acuity/monitored beds are often in high demand, and their unavailability may sometimes mean cancellation of surgery or prolonged patient stay in the Post-operative Recovery Room, further causing operating room backlog.
Read more
Another serious issue is that many patients do not know they actually have the OSA condition. It is estimated that up to 20% (1) of people in the general public have OSA and that 75% (2) of them are not diagnosed. When someone with OSA goes for surgery without previously being diagnosed, special precautions in care and monitoring may not be in place, until a complication develops. For this reason, this population - those most susceptible to have OSA, but with no previous formal testing for the condition - is the most at risk for complications, and is the target group for this trial.
We plan to identify the study population by screening for OSA using the STOP-BANG questionnaire. Those who score high on this 8 item screening test have high likelihood of actually having OSA if they were to undergo formal testing and diagnosis in a Sleep Lab.
We will identify cardio-respiratory complications by conducting a chart review and determine whether admission to a "high acuity" bed had any impact. As OSA patients are at higher risk for cardiovascular complications at baseline and around the time of surgery, blood test for troponin will be performed on post-op day 1 and 2 to investigate the rate of myocardial injury. With the rate of MINS (myocardial injury after non-cardiac surgery) reported to be 8% with almost 10% 30 day mortality (per VISION trial), this pilot project which focuses on arthroplasty patients with suspected OSA, will inform us of the arthroplasty surgery specific MINS risk for comparison.
- Conditions
- Obstructive Sleep Apnea
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Suspected OSA Patients Undergoing Knee or Hip Arthroplasty | These 100 subjects will be cared for and monitored in hospital following current hospital protocol. No change or intervention is to be administered. Troponin testing will be done post-op with other routine blood work. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Adverse Events
The incidence of adverse events (each listed as a secondary outcome) related to OSA combined as a composite end point
Measured: 0-96 hours
Troponin
Testing for risk of MINS (myocardial injury after non-cardiac surgery)
Measured: Post-op Day 1
Troponin
Testing for risk of MINS (myocardial injury after non-cardiac surgery)
Measured: Post-op Day 2
Secondary outcomes (9)
Respiratory or Cardiac Arrest
Activation of Code Blue
Measured: 0-96 hours
Respiratory Therapy beyond standard nasal prong oxygen
Measured: 0-96 hours
Pneumonia
Fever with temp >=38 degree Celsius, leukocytosis and new infiltrate on CXR
Measured: 0-96 hours
Naloxone Usage
For opioid reversal
Measured: 0-96 hours
Airway Intervention for any cause
Use of nasal/oral airway or intubation, jaw thrust/chin lift
Measured: 0-96 hours
Cardiac Arrhythmia
New arrhythmia requiring treatment
Measured: 0-96 hours
Cardiac ischemia or injury
ECG changes or troponin elevation
Measured: 0-48 hours
Transfer from normal ward bed to monitored bed
Measured: 0-96 hours
Transfer to local tertiary hospital
Measured: 0-96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start4 Dec 2017
- Primary completion1 Aug 2018
- Study completion12 Oct 2018
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 Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Vancouver Coastal Health Research Institute
- Responsible party
- Principal investigator, Steven Lee, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03281408
- Sponsor's protocol ID
- H17-01022
- Status last verified
- Mar 2019
- First submitted
- 11 Sep 2017
- Last updated
- 18 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Peppard PE, Young T, Barnet JH, Palta M, Hagen EW, Hla KM. Increased prevalence of sleep-disordered breathing in adults. Am J Epidemiol. 2013 May 1;177(9):1006-14. doi: 10.1093/aje/kws342. Epub 2013 Apr 14.
PubMed 23589584Punjabi NM. The epidemiology of adult obstructive sleep apnea. Proc Am Thorac Soc. 2008 Feb 15;5(2):136-43. doi: 10.1513/pats.200709-155MG.
PubMed 18250205
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Obstructive Sleep Apnea Intervention Study
- ClinicalTrials.gov ID
- NCT03281408
- Acronym / sponsor ID
- H17-01022
- Conditions
- Obstructive Sleep Apnea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Vancouver Coastal Health Research Institute
- Study start
- 4 Dec 2017 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 12 Oct 2018 (actual)
- First posted
- 13 Sep 2017 (actual)
- 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.
Obstructive Sleep Apnea (OSA) is a common and under-diagnosed breathing disorder characterized by recurrent partial or complete collapse of the upper airway (tongue, soft palate) during sleep. It causes recurrent episodes of asphyxia (suffocation) resulting in fragmented sleep, low blood oxygen levels (hypoxemia), and high carbon dioxide concentrations. Untreated OSA is associated with serious heart/lung and metabolic diseases including strokes, diabetes, and heart attacks.
When a patient with OSA undergoes surgery, the symptoms of OSA are exacerbated afterwards due to the effects of anesthesia and related medications such as those used for pain control. This puts patients at higher risk for complications and necessitates nursing care and monitoring that are resource intensive. In many hospitals, patients with an OSA diagnosis are monitored after surgery in "high acuity" wards where the nurse to patient ratio is higher than usual. These high acuity/monitored beds are often in high demand, and their unavailability may sometimes mean cancellation of surgery or prolonged patient stay in the Post-operative Recovery Room, further causing operating room backlog.
Another serious issue is that many patients do not know they actually have the OSA condition. It is estimated that up to 20% (1) of people in the general public have OSA and that 75% (2) of them are not diagnosed. When someone with OSA goes for surgery without previously being diagnosed, special precautions in care and monitoring may not be in place, until a complication develops. For this reason, this population - those most susceptible to have OSA, but with no previous formal testing for the condition - is the most at risk for complications, and is the target group for this trial.
We plan to identify the study population by screening for OSA using the STOP-BANG questionnaire. Those who score high on this 8 item screening test have high likelihood of actually having OSA if they were to undergo formal testing and diagnosis in a Sleep Lab.
We will identify cardio-respiratory complications by conducting a chart review and determine whether admission to a "high acuity" bed had any impact. As OSA patients are at higher risk for cardiovascular complications at baseline and around the time of surgery, blood test for troponin will be performed on post-op day 1 and 2 to investigate the rate of myocardial injury. With the rate of MINS (myocardial injury after non-cardiac surgery) reported to be 8% with almost 10% 30 day mortality (per VISION trial), this pilot project which focuses on arthroplasty patients with suspected OSA, will inform us of the arthroplasty surgery specific MINS risk for comparison.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suspected OSA Patients Undergoing Knee or Hip Arthroplasty | – | –These 100 subjects will be cared for and monitored in hospital following current hospital protocol. No change or intervention is to be administered. Troponin testing will be done post-op with other routine blood work. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred to the UBC Hospital to have knee/hip arthroplasty surgery.
Key inclusion criteria (2 listed)
- Patients undergoing elective primary or revision knee/hip replacement surgery.
- Patients with no previous OSA diagnosis (by polysomnography), who score >=5 on STOP-BANG OSA screening.
Key exclusion criteria (3 listed)
- Patients without ability to communicate in English by reading or writing.
- Patients with renal failure.
- Patients on CPAP therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Composite Adverse Events
Time frame: 0-96 hours
The incidence of adverse events (each listed as a secondary outcome) related to OSA combined as a composite end point
Troponin
Time frame: Post-op Day 1
Testing for risk of MINS (myocardial injury after non-cardiac surgery)
Troponin
Time frame: Post-op Day 2
Testing for risk of MINS (myocardial injury after non-cardiac surgery)
9 secondary outcomes
Respiratory or Cardiac Arrest
Time frame: 0-96 hours
Respiratory Therapy beyond standard nasal prong oxygen
Time frame: 0-96 hours
Pneumonia
Time frame: 0-96 hours
Naloxone Usage
Time frame: 0-96 hours
Airway Intervention for any cause
Time frame: 0-96 hours
Cardiac Arrhythmia
Time frame: 0-96 hours
Cardiac ischemia or injury
Time frame: 0-48 hours
Transfer from normal ward bed to monitored bed
Time frame: 0-96 hours
Transfer to local tertiary hospital
Time frame: 0-96 hours
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 18 Mar 2019.
- Background: PubMed 23589584Peppard PE, Young T, Barnet JH, Palta M, Hagen EW, Hla KM. Increased prevalence of sleep-disordered breathing in adults. Am J Epidemiol. 2013 May 1;177(9):1006-14. doi: 10.1093/aje/kws342. Epub 2013 Apr 14.
- Background: PubMed 18250205Punjabi NM. The epidemiology of adult obstructive sleep apnea. Proc Am Thorac Soc. 2008 Feb 15;5(2):136-43. doi: 10.1513/pats.200709-155MG.
- Individual participant dataSharing planned: No
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Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by University of British Columbia 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 2 inclusion and 3 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 18 Mar 2019. 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.
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?
Composite Adverse Events (time frame: 0-96 hours). The study lists 3 primary outcomes in all. 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 NCT03281408, 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 18 Mar 2019.