Obstructive Sleep Apnea of AdultNCT03325153
Obstructive Sleep Apnea and Bronchoscopy
An observational study of Obstructive Sleep Apnea of Adult, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The prevalence of sleep-disordered breathing in Republic of Korea is 27% and 16% in men and women aged 40-69 years. Up to 93% of women and 82% of men with obstructive sleep apnea (OSA) remain undiagnosed. Polysomnography, the gold standard, is time consuming and costly. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Obstructive Sleep Apnea of Adult
- How many people
- 546 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Dec 2016to 27 Dec 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Tertiary referral hospital
Who may be able to join
- Patients who are18 years or order undergoing bronchoscopy with conscious sedation in the bronchoscopy center
Who cannot join
- Previous diagnosis of OSA
- American Society of Anesthesiologists Physical Status Classification System score > 3
- Baseline SpO2 < 90% or need for supplemental oxygen before the procedure
- Tracheostomy tubes
- An inability to provide informed consent
- Undergoing the procedure based on an outpatient clinic
Show all 9Show fewer
- Undergoing BAL, EBUS-TBNA, and interventional bronchoscopy
- Allergies or sensitivities to sedative medications
- Pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Screening for Obstructive Sleep Apnea Predicts Cardiopulmonary Events in Patients Undergoing Bronchoscopy
The prevalence of sleep-disordered breathing in Republic of Korea is 27% and 16% in men and women aged 40-69 years. Up to 93% of women and 82% of men with obstructive sleep apnea (OSA) remain undiagnosed. Polysomnography, the gold standard, is time consuming and costly. Patients with undiagnosed OSA may experience obstructive episodes during procedures with conscious sedation.
STOP-Bang questionnaire is the validated questionnaire to screen patients for undiagnosed OSA in the preoperative setting. It has high sensitivity (92.9%) for predicting patients with moderate to severe OSA.
Previous studies reported that STOP-Bang questionnaire predicted cardiopulmonary events during advanced endoscopic procedures such as endoscopic retrograde cholangiopancreatography (ERCP) and endoscopic ultrasound. However, there have been no studies regarding the risk for sedation-related cardiopulmonary events in patients with undiagnosed OSA undergoing bronchoscopy. Thus, we aimed to evaluate the prevalence of high-risk patients for OSA by a screening questionnaire, and to determine whether the questionnaire could predict patients who are at risk for cardiopulmonary events during bronchoscopy with conscious sedation.
- Conditions
- Obstructive Sleep Apnea of Adult
- Keywords
- Obstructive Sleep Apnea, Bronchoscopy, STOP-Bang questionnaire, Cardiopulmonary events
- Medical subject headings
- Sleep Apnea, Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiopulmonary events
Hypoxemia (SpO2 < 90%) or Hypotension (SBP < 90 mm Hg or a decrease of more than 25% from the baseline)
Measured: Any time during bronchoscopy under conscious sedation (procedure)
Secondary outcomes (1)
Airway maneuvers
Chin lift or Bag-mask ventilation or Unplanned endotracheal intubation
Measured: Any time during bronchoscopy under conscious sedation (procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2017
- Study start27 Dec 2016
- Primary completion21 Sep 2018
- Study completion27 Dec 2018
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 Obstructive Sleep Apnea of AdultStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Cross-sectional
- Enrolment
- 546 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinwoo Lee, Seoul National University Hospital
- Investigators
- Jinwoo Lee, MD, Principal investigator, Seoul National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03325153
- Sponsor's protocol ID
- 1612041813
- Status last verified
- Dec 2019
- First submitted
- 25 Oct 2017
- Last updated
- 12 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cho J, Choi SM, Park YS, Lee CH, Lee SM, Yoo CG, Kim YW, Lee J. Prediction of cardiopulmonary events using the STOP-Bang questionnaire in patients undergoing bronchoscopy with moderate sedation. Sci Rep. 2020 Sep 2;10(1):14471. doi: 10.1038/s41598-020-71314-1.
PubMed 32879339
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Obstructive Sleep Apnea Predicts Cardiopulmonary Events in Patients Undergoing Bronchoscopy
- ClinicalTrials.gov ID
- NCT03325153
- Acronym / sponsor ID
- 1612041813
- Conditions
- Obstructive Sleep Apnea of Adult
- Keywords
- Obstructive Sleep Apnea, Bronchoscopy, STOP-Bang questionnaire, Cardiopulmonary events
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 546 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 27 Dec 2016 (actual)
- Primary completion
- 21 Sep 2018 (actual)
- Study completion
- 27 Dec 2018 (actual)
- First posted
- 30 Oct 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.
The prevalence of sleep-disordered breathing in Republic of Korea is 27% and 16% in men and women aged 40-69 years. Up to 93% of women and 82% of men with obstructive sleep apnea (OSA) remain undiagnosed. Polysomnography, the gold standard, is time consuming and costly. Patients with undiagnosed OSA may experience obstructive episodes during procedures with conscious sedation.
STOP-Bang questionnaire is the validated questionnaire to screen patients for undiagnosed OSA in the preoperative setting. It has high sensitivity (92.9%) for predicting patients with moderate to severe OSA.
Previous studies reported that STOP-Bang questionnaire predicted cardiopulmonary events during advanced endoscopic procedures such as endoscopic retrograde cholangiopancreatography (ERCP) and endoscopic ultrasound. However, there have been no studies regarding the risk for sedation-related cardiopulmonary events in patients with undiagnosed OSA undergoing bronchoscopy. Thus, we aimed to evaluate the prevalence of high-risk patients for OSA by a screening questionnaire, and to determine whether the questionnaire could predict patients who are at risk for cardiopulmonary events during bronchoscopy with conscious sedation.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Tertiary referral hospital
Key inclusion criteria (1 listed)
- Patients who are18 years or order undergoing bronchoscopy with conscious sedation in the bronchoscopy center
Key exclusion criteria (9 listed)
- Previous diagnosis of OSA
- American Society of Anesthesiologists Physical Status Classification System score > 3
- Baseline SpO2 < 90% or need for supplemental oxygen before the procedure
- Tracheostomy tubes
- An inability to provide informed consent
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
Cardiopulmonary events
Time frame: Any time during bronchoscopy under conscious sedation (procedure)
Hypoxemia (SpO2 < 90%) or Hypotension (SBP < 90 mm Hg or a decrease of more than 25% from the baseline)
1 secondary outcome
Airway maneuvers
Time frame: Any time during bronchoscopy under conscious sedation (procedure)
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 12 Dec 2019.
- Derived from this study: PubMed 32879339Cho J, Choi SM, Park YS, Lee CH, Lee SM, Yoo CG, Kim YW, Lee J. Prediction of cardiopulmonary events using the STOP-Bang questionnaire in patients undergoing bronchoscopy with moderate sedation. Sci Rep. 2020 Sep 2;10(1):14471. doi: 10.1038/s41598-020-71314-1.
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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.
Jinwoo Lee, MD principal investigator
Seoul National University
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 of Adult, run by Seoul National University Hospital at 1 site in South Korea.
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 1 inclusion and 9 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 12 Dec 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 South Korea. 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?
Cardiopulmonary events (time frame: Any time during bronchoscopy under conscious sedation (procedure)). 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 NCT03325153, 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 12 Dec 2019.