Skip to main content
OpenTrials
Completed

NCT Number: NCT03325153

Obstructive Sleep Apnea and 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obstructive Sleep Apnea of Adult Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, 110744, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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)

Secondary outcomes

  1. Airway maneuvers

    Time frame: Any time during bronchoscopy under conscious sedation (procedure)

    Chin lift or Bag-mask ventilation or Unplanned endotracheal intubation

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Screening for Obstructive Sleep Apnea Predicts Cardiopulmonary Events in Patients Undergoing Bronchoscopy

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 30, 2017
Registry last updated
Dec 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.