Obstructive Sleep Apnea and Bronchoscopy
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|ClinicalTrials.gov Identifier: NCT03325153|
Recruitment Status : Recruiting
First Posted : October 30, 2017
Last Update Posted : October 30, 2017
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.
|Condition or disease|
|Obstructive Sleep Apnea of Adult|
|Study Type :||Observational|
|Estimated Enrollment :||664 participants|
|Official Title:||Screening for Obstructive Sleep Apnea Predicts Cardiopulmonary Events in Patients Undergoing Bronchoscopy|
|Actual Study Start Date :||December 2016|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
- 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)
- Airway maneuvers [ Time Frame: Any time during bronchoscopy under conscious sedation (procedure) ]Chin lift or Bag-mask ventilation or Unplanned endotracheal intubation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03325153
|Contact: Jinwoo Lee, MDfirstname.lastname@example.org|
|Korea, Republic of|
|Seoul National University Hospital||Recruiting|
|Seoul, Korea, Republic of, 110744|
|Contact: Jinwoo Lee, MD 82-2-2072-7593 email@example.com|
|Principal Investigator:||Jinwoo Lee, MD||Seoul National University|