Obstructive Sleep Apnea and Bronchoscopy

NCT03325153 | Completed

• 1 other identifier: 1612041813
• Study Type: observational
• Target: 546
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea of Adult

Keywords

Obstructive Sleep Apnea; Bronchoscopy; STOP-Bang questionnaire; Cardiopulmonary events

Outcome Measures

Primary Outcomes (1)

• Cardiopulmonary events

  Hypoxemia (SpO2 \< 90%) or Hypotension (SBP \< 90 mm Hg or a decrease of more than 25% from the baseline)

  Any time during bronchoscopy under conscious sedation (procedure)

Secondary Outcomes (1)

• Airway maneuvers

  Any time during bronchoscopy under conscious sedation (procedure)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Tertiary referral hospital

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110744, South Korea

Location

Related Publications (1)

• 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.

  PMID: 32879339 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Jinwoo Lee, MD

  Seoul National University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: October 25, 2017
• First Posted: October 30, 2017
• Study Start: December 27, 2016
• Primary Completion: September 21, 2018
• Study Completion: December 27, 2018
• Last Updated: December 12, 2019

Record last verified: 2019-12

Locations

KR (1)