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临床试验/NCT03325153
NCT03325153已完成不适用

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

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 546 人开始时间: 2016年12月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
546
试验地点
1
主要终点
Cardiopulmonary events

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Cardiopulmonary events

时间窗: 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)

次要结局

  • Airway maneuvers(Any time during bronchoscopy under conscious sedation (procedure))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jinwoo Lee

Associate professor

Seoul National University Hospital

研究点 (1)

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