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临床试验/NCT04443582
NCT04443582已完成不适用

An Exploratory Study of Correlating Point Of Care Ultrasound (POCUS) Measures of Sleep Apnea With STOP-BANG Scoring and Apnea-Hypopnea Index (AHI)

Rakesh Sondekoppam Vijayashankar1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2020年6月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
140
试验地点
1
主要终点
Correlation of POCUS measurements with AHI and/or STOP-Bang Scores

研究概览

简要总结

Patients with obstructive sleep apnea (OSA) are at risk for respiratory dysfunction in the perioperative environment. The study is designed to evaluate if point-of-care-ultrasound (POCUS) measurements of upper airway anatomy may identify patients with OSA and their severity.

详细描述

Obstructive sleep apnea (OSA) is characterized by recurrent collapse of the pharyngeal airway during sleep, resulting in substantially reduced (hypopnea) or complete cessation (apnea) of airflow despite ongoing breathing efforts. OSA has long been recognized as a heterogeneous disorder with potentially multiple contributing pathophysiological causes but with significant impact to perioperative morbidity. Various OSA phenotypes exist but, the predominant feature is a narrow and collapsible upper airway anatomy and is an interplay between pharyngeal soft tissue, genioglossus muscle tone and the bony anatomy and accounts for up to two-thirds of the variation in the AHI. Identification of moderate-severe OSA is crucial to prevent potential life-threatening cardiopulmonary complications perioperatively.(1) However, a large proportion of patients with OSA remain undiagnosed at the time of surgery.(2) Current screening tools are mainly questionnaire based and are largely sensitive but not specific (3) resulting in many false positives, unnecessary increased resource utilization, cost burden, and legal implications. Gold standard laboratory polysomnography(PSG) study is expensive and not widely available. Point-of-care ultrasound (POCUS) is a readily available, portable, noninvasive tool that has been used for airway evaluation and may be useful for OSA screening.(4-8) Study investigators want to evaluate the various POCUS measures of OSA in the perioperative population and correlate these measurements with the PSG based severity of OSA (based on apnea-hypopnea index -AHI) to find out the best measure or a combination of measures to diagnose the incidence and severity of OSA.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients of either gender
  • Age 18 through 85
  • History of previous sleep study polysomnography (PSG)

排除标准

  • No prior sleep study
  • History of central sleep apnea
  • Craniofacial/oropharyngeal malformations
  • Oropharyngeal surgery since the last sleep study
  • Ear/Nose/Throat tumor
  • History of Ear/Nose/Throat surgery
  • Inability to consent
  • Non-English speaking

结局指标

主要结局

Correlation of POCUS measurements with AHI and/or STOP-Bang Scores

时间窗: 1 day

The study is designed to assess if there is a correlation of one or a combination of point-of-care-ultrasound measurements with the severity of OSA as denoted by apnea-hypopnea index (AHI) from previous sleep study and/or STOP-Bang scores noted for the presence of OSA in screening exam prior to surgical procedures that require intubation. STOP-Bang denotes Snoring, Tired, Observed (anyone observed you stop breathing), Pressure (high blood pressure), Body mass index (more than 35 kg/m2), Age (older than 50), Neck size, Gender

次要结局

未报告次要终点

研究者

发起方
Rakesh Sondekoppam Vijayashankar
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Rakesh Sondekoppam Vijayashankar

Principle Investigator

University of Iowa

研究点 (1)

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