Clinical trial NCT03325153: Obstructive Sleep Apnea and Bronchoscopy
Official title: Screening for Obstructive Sleep Apnea Predicts Cardiopulmonary Events in Patients Undergoing Bronchoscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea of Adult
Keywords: Obstructive Sleep Apnea
Bronchoscopy
STOP-Bang questionnaire
Cardiopulmonary events
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-10-30
Enrollment: 546
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Tertiary referral hospital

Brief 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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: Cardiopulmonary events
timeFrame: Any time during bronchoscopy under conscious sedation (procedure)
Secondary outcomes:
measure: Airway maneuvers
timeFrame: Any time during bronchoscopy under conscious sedation (procedure)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University
name: Jinwoo Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.