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临床试验/NCT03281408
NCT03281408已完成不适用

Perioperative Obstructive Sleep Apnea Intervention Study

University of British Columbia1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年12月4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
100
试验地点
1
主要终点
Composite Adverse Events

研究概览

简要总结

Obstructive Sleep Apnea (OSA) is a common and under-diagnosed breathing disorder characterized by recurrent partial or complete collapse of the upper airway (tongue, soft palate) during sleep. It causes recurrent episodes of asphyxia (suffocation) resulting in fragmented sleep, low blood oxygen levels (hypoxemia), and high carbon dioxide concentrations. Untreated OSA is associated with serious heart/lung and metabolic diseases including strokes, diabetes, and heart attacks.

When a patient with OSA undergoes surgery, the symptoms of OSA are exacerbated afterwards due to the effects of anesthesia and related medications such as those used for pain control. This puts patients at higher risk for complications and necessitates nursing care and monitoring that are resource intensive. In many hospitals, patients with an OSA diagnosis are monitored after surgery in "high acuity" wards where the nurse to patient ratio is higher than usual. These high acuity/monitored beds are often in high demand, and their unavailability may sometimes mean cancellation of surgery or prolonged patient stay in the Post-operative Recovery Room, further causing operating room backlog.

Another serious issue is that many patients do not know they actually have the OSA condition. It is estimated that up to 20% (1) of people in the general public have OSA and that 75% (2) of them are not diagnosed. When someone with OSA goes for surgery without previously being diagnosed, special precautions in care and monitoring may not be in place, until a complication develops. For this reason, this population - those most susceptible to have OSA, but with no previous formal testing for the condition - is the most at risk for complications, and is the target group for this trial.

We plan to identify the study population by screening for OSA using the STOP-BANG questionnaire. Those who score high on this 8 item screening test have high likelihood of actually having OSA if they were to undergo formal testing and diagnosis in a Sleep Lab.

We will identify cardio-respiratory complications by conducting a chart review and determine whether admission to a "high acuity" bed had any impact. As OSA patients are at higher risk for cardiovascular complications at baseline and around the time of surgery, blood test for troponin will be performed on post-op day 1 and 2 to investigate the rate of myocardial injury. With the rate of MINS (myocardial injury after non-cardiac surgery) reported to be 8% with almost 10% 30 day mortality (per VISION trial), this pilot project which focuses on arthroplasty patients with suspected OSA, will inform us of the arthroplasty surgery specific MINS risk for comparison.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Patients undergoing elective primary or revision knee/hip replacement surgery.
  • Patients with no previous OSA diagnosis (by polysomnography), who score >=5 on STOP-BANG OSA screening.

排除标准

  • Patients without ability to communicate in English by reading or writing.
  • Patients with renal failure.
  • Patients on CPAP therapy.

结局指标

主要结局

Composite Adverse Events

时间窗: 0-96 hours

The incidence of adverse events (each listed as a secondary outcome) related to OSA combined as a composite end point

Troponin

时间窗: Post-op Day 2

Testing for risk of MINS (myocardial injury after non-cardiac surgery)

次要结局

  • Cardiac Arrhythmia(0-96 hours)
  • Pneumonia(0-96 hours)
  • Naloxone Usage(0-96 hours)
  • Respiratory or Cardiac Arrest(0-96 hours)
  • Respiratory Therapy beyond standard nasal prong oxygen(0-96 hours)
  • Airway Intervention for any cause(0-96 hours)
  • Cardiac ischemia or injury(0-48 hours)
  • Transfer from normal ward bed to monitored bed(0-96 hours)
  • Transfer to local tertiary hospital(0-96 hours)

研究者

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

Steven Lee

Clinical Assistant Professor

University of British Columbia

研究点 (1)

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