Obstructive Sleep Apnea and Bronchoscopy

NCT ID: NCT03325153

Last Updated: 2019-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

546 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-27

Study Completion Date

2018-12-27

Brief Summary

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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.

Detailed Description

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Conditions

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Obstructive Sleep Apnea of Adult

Keywords

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Obstructive Sleep Apnea Bronchoscopy STOP-Bang questionnaire Cardiopulmonary events

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* Patients who are18 years or order undergoing bronchoscopy with conscious sedation in the bronchoscopy center

Exclusion Criteria

* 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
* Undergoing BAL, EBUS-TBNA, and interventional bronchoscopy
* Allergies or sensitivities to sedative medications
* Pregnant
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jinwoo Lee

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jinwoo Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 32879339 (View on PubMed)

Other Identifiers

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1612041813

Identifier Type: -

Identifier Source: org_study_id