Obstructive Sleep ApneaNCT02123225
Is the STOP-BANG Predictive of Worsening OSA in the Early Postop Period in Patients Undergoing TJA?
An observational study of Obstructive Sleep Apnea and Total Knee Arthroplasty, run by United States Naval Medical Center, San Diego at 1 site in United States.
Trial summary
The goal of this study is to determine if the investigators can use the STOP-BANG score to identify those patients at risk for worsening Obstructive Sleep Apnea (OSA) symptoms in the early postoperative period after major surgery. Hypotheses: 1. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Obstructive Sleep Apnea, Total Knee Arthroplasty
- How many people
- 93 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to 12 May 2017
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The subject population will be N = 168 patients scheduled for primary or revision TKA between the ages of 18-90, at Naval Medical Center San Diego.
Who may be able to join
- Age 18-90
- Scheduled for primary or revision TKA
- Able to read and understand the consent
- Able to complete an unattended OSA PM examination at home 1-60 days prior to surgery and for three days postoperatively
Who cannot join
- Polysomnography confirmed OSA
- Significant comorbid medical conditions that may degrade the accuracy of PM (moderate to severe pulmonary disease, neuromuscular disease, or congestive heart failure)
Trial locations and contacts
1 site in 1 country.
United States1 site
Naval Medical Center San Diego
San Diego, California, 92134
About this study
Official title: Is the STOP-BANG Predictive of Worsening Obstructive Sleep Apnea in the Early Postoperative Period in Patients Undergoing Total Joint Arthroplasty?
The goal of this study is to determine if the investigators can use the STOP-BANG score to identify those patients at risk for worsening Obstructive Sleep Apnea (OSA) symptoms in the early postoperative period after major surgery.
Hypotheses:
- - Postoperative sleep apnea parameters will be worse when compared to baseline in patients with higher scores on the STOP-BANG.
- - A higher STOP-BANG score will be predictive of worsening sleep apnea parameters in patients undergoing Total Knee Arthroscopy (TKA).
Read the detailed description
Obstructive sleep apnea (OSA) is associated with increased morbidity and mortality after total knee arthroplasty (TKA). Up to 30% of surgical patients have undiagnosed OSA; however, many patients are unable to obtain a sleep study prior to surgery. In recent years the STOP-BANG questionnaire (8 yes-no questions; ≥3 high-risk OSA) has become one of the most common tools used in the preoperative period to identify patients at high-risk for OSA. However, further research is needed to determine if the STOP-BANG is predictive of worsening of sleep apnea parameters in patients undergoing TKA.
The purpose of this prospective observational cohort study is to determine in TKA patients if the score on the STOP-BANG (<3, ≥3 to <5, or ≥5) is predictive of worsening sleep apnea parameters (AHI, time with SPO2 <90% \& 85% [T90 \& T85], lowest oxygen saturation [LSAT], \& number of central apneas) during the first three days after surgery. The investigators propose to enroll N = 168 patients undergoing TKA at NMCSD who are receiving multimodal anesthesia/analgesia for surgery. Patients will complete a baseline unattended sleep study prior to surgery then again for the first three days after surgery. Patients will be categorized into three groups based on their STOP-BANG score (<3, ≥3 to <5, or ≥5) and the investigators will first compare the groups to identify if there are differences between baseline and postoperative sleep apnea parameters based on the STOP-BANG groups (<3, ≥3 to <5, or ≥5). If differences are found the investigators will use multiple regression analysis to determine if the STOP-BANG scores or categories and/or other covariates (i.e., comorbidity index, total morphine equivalents) are predictive of worsening sleep apnea during the first three days after surgery.
Results of this study may help improve patient safety by allowing us to identify which group of TKA patients with undiagnosed OSA may require more intensive postoperative monitoring and therapy (i.e, ICU admission, need for continuous end-tidal CO2 monitoring, postoperative positive airway pressure therapy) or change in the analgesic plan.
- Conditions
- Obstructive Sleep Apnea, Total Knee Arthroplasty
- Keywords
- STOP-BANG, Obstructive sleep apnea (OSA), total knee arthroplasty (TKA), portable monitoring, sleep medicine, unattended sleep study, postoperative sleep study
- Medical subject headings
- Sleep Apnea, Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Apnea Hypopnea Index
Measuring changes in the apnea hypopnea index on postoperative nights 1, 2, and 3 with unattended polysomnography.
Measured: Baseline through postoperative night 3
Secondary outcomes (2)
Change in time with oxygen saturation <85%
Measuring changes in the total time with oxygen saturations <85% on postoperative nights 1, 2 \& 3 with unattended polysomnography.
Measured: Baseline through postoperative night 3
Change in time with oxygen saturation <90%
Measuring changes in the total time with oxygen saturations <90% on postoperative nights 1, 2 \& 3 with unattended polysomnography.
Measured: Baseline through postoperative night 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2014 (estimated)
- Study startDec 2013
- Primary completionNov 2016
- Study completion12 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Naval Medical Center, San Diego
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Dennis Spence, United States Naval Medical Center, San Diego
- Investigators
- Dennis L Spence, PhD, Principal investigator, United States Naval Medical Center, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02123225
- Sponsor's protocol ID
- NMCSD.2013.0045
- Status last verified
- Sep 2017
- First submitted
- 21 Apr 2014
- Last updated
- 21 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the STOP-BANG Predictive of Worsening Obstructive Sleep Apnea in the Early Postoperative Period in Patients Undergoing Total Joint Arthroplasty?
- ClinicalTrials.gov ID
- NCT02123225
- Acronym / sponsor ID
- NMCSD.2013.0045
- Conditions
- Obstructive Sleep Apnea, Total Knee Arthroplasty
- Keywords
- STOP-BANG, Obstructive sleep apnea (OSA), total knee arthroplasty (TKA), portable monitoring, sleep medicine, unattended sleep study, postoperative sleep study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- United States Naval Medical Center, San DiegoUS federal agency
- Study start
- Dec 2013
- Primary completion
- Nov 2016 (actual)
- Study completion
- 12 May 2017 (actual)
- First posted
- 25 Apr 2014 (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 goal of this study is to determine if the investigators can use the STOP-BANG score to identify those patients at risk for worsening Obstructive Sleep Apnea (OSA) symptoms in the early postoperative period after major surgery.
Hypotheses:
- - Postoperative sleep apnea parameters will be worse when compared to baseline in patients with higher scores on the STOP-BANG.
- - A higher STOP-BANG score will be predictive of worsening sleep apnea parameters in patients undergoing Total Knee Arthroscopy (TKA).
Detailed description
Obstructive sleep apnea (OSA) is associated with increased morbidity and mortality after total knee arthroplasty (TKA). Up to 30% of surgical patients have undiagnosed OSA; however, many patients are unable to obtain a sleep study prior to surgery. In recent years the STOP-BANG questionnaire (8 yes-no questions; ≥3 high-risk OSA) has become one of the most common tools used in the preoperative period to identify patients at high-risk for OSA. However, further research is needed to determine if the STOP-BANG is predictive of worsening of sleep apnea parameters in patients undergoing TKA.
The purpose of this prospective observational cohort study is to determine in TKA patients if the score on the STOP-BANG (<3, ≥3 to <5, or ≥5) is predictive of worsening sleep apnea parameters (AHI, time with SPO2 <90% \& 85% [T90 \& T85], lowest oxygen saturation [LSAT], \& number of central apneas) during the first three days after surgery. The investigators propose to enroll N = 168 patients undergoing TKA at NMCSD who are receiving multimodal anesthesia/analgesia for surgery. Patients will complete a baseline unattended sleep study prior to surgery then again for the first three days after surgery. Patients will be categorized into three groups based on their STOP-BANG score (<3, ≥3 to <5, or ≥5) and the investigators will first compare the groups to identify if there are differences between baseline and postoperative sleep apnea parameters based on the STOP-BANG groups (<3, ≥3 to <5, or ≥5). If differences are found the investigators will use multiple regression analysis to determine if the STOP-BANG scores or categories and/or other covariates (i.e., comorbidity index, total morphine equivalents) are predictive of worsening sleep apnea during the first three days after surgery.
Results of this study may help improve patient safety by allowing us to identify which group of TKA patients with undiagnosed OSA may require more intensive postoperative monitoring and therapy (i.e, ICU admission, need for continuous end-tidal CO2 monitoring, postoperative positive airway pressure therapy) or change in the analgesic plan.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The subject population will be N = 168 patients scheduled for primary or revision TKA between the ages of 18-90, at Naval Medical Center San Diego.
Key inclusion criteria (4 listed)
- Age 18-90
- Scheduled for primary or revision TKA
- Able to read and understand the consent
- Able to complete an unattended OSA PM examination at home 1-60 days prior to surgery and for three days postoperatively
Key exclusion criteria (2 listed)
- Polysomnography confirmed OSA
- Significant comorbid medical conditions that may degrade the accuracy of PM (moderate to severe pulmonary disease, neuromuscular disease, or congestive heart failure)
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
Change in Apnea Hypopnea Index
Time frame: Baseline through postoperative night 3
Measuring changes in the apnea hypopnea index on postoperative nights 1, 2, and 3 with unattended polysomnography.
2 secondary outcomes
Change in time with oxygen saturation <85%
Time frame: Baseline through postoperative night 3
Change in time with oxygen saturation <90%
Time frame: Baseline through postoperative night 3
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 21 Sep 2017.
- 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.
Dennis L Spence, PhD principal investigator
United States Naval Medical Center, San Diego
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 and Total Knee Arthroplasty, run by United States Naval Medical Center, San Diego at 1 site in United States.
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 4 inclusion and 2 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 21 Sep 2017. 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 United States. 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?
Change in Apnea Hypopnea Index (time frame: Baseline through postoperative night 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Sep 2017.