Obstructive Sleep Apnea and Bronchoscopy

Obstructive Sleep Apnea of Adult Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03325153
• Other study ID #: 1612041813
• Status: Completed
• Start date: December 27, 2016
• Est. completion date: December 27, 2018

Study information

• Verified date: December 2019
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 546
• Est. completion date: December 27, 2018
• Est. primary completion date: September 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea of Adult
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Airway maneuvers	Chin lift or Bag-mask ventilation or Unplanned endotracheal intubation	Any time during bronchoscopy under conscious sedation (procedure)