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临床试验/NCT06453538
NCT06453538招募中不适用

Sleep Quality and Sleep-disordered Breathing in Bypass Surgery Patients

Turku University Hospital1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2023年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
54
试验地点
1
主要终点
Incidence of sleep disorders before coronary artery bypass surgery (CABG), polysomnography

研究概览

简要总结

Patients undergoing non-emergency coronary artery bypass surgery (CABG) are included. All patients will be examined for transthoracic echo, blood samples will be collected, and an overnight sleep polygraph will be performed in a qualified sleep laboratory twice: once before CABG and again after surgery

详细描述

Detailed Description:

Our hypothesis is that sleep-related apneas are increasing following coronary artery bypass surgery, and sleep quality may deteriorate. We are attempting to determine the causes of these difficulties, which are caused by microemboli in the brain from the use of a heart-lung machine, brain infarction induced by major surgery, thoracic tissue trauma following surgery, or complications during perioperative care. The hypothesis is that postoperative outcomes and recovery are related if a patient is identified with sleep apnea before CABG surgery. A sleep polygraph is performed before surgery and again around six months after, as well as a transthoracic echo and laboratory tests. If a link between sleep quality and coronary bypass surgery can be established, the results can be employed in clinical practice.

The total amount of patients operated on heart-lung machine is anticipated to be 70. The off-pump patient sample size is remarkably smaller, so data is collected and compared with the main sample population. The operation technique is decided when the patient is scheduled for operation. Emergency patients are excluded because pre-operative examinations cannot be performed. Other exclusion criteria are nighttime CPAP- treatment and other heart operations (for example valve surgery) during CABG.

Basic information including age, weight, height, diseases, medications, and medical history are collected from all patients. ECG is registered before and after surgery and sinus or other heart rhythms are recorded. Sleep polygraph is done preoperatively and postoperatively when the patient is fully recovered from surgery (at 6 months or more).

研究设计

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

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Elective coronary artery bypass surgery

排除标准

  • Emergency cabg
  • Night time cpap- treatment
  • other heart operations (for example valve surgery)

结局指标

主要结局

Incidence of sleep disorders before coronary artery bypass surgery (CABG), polysomnography

时间窗: Before operation, as soon as operation has scheduled

Apnea-hypopnea index (AHI). Number of apneas and hypopneas that occur per hour of sleep. According to the American Academy of Sleep Medicine (AASM) it is categorized into mild (5-15 events/hour), moderate (15-30 events/hr), and severe (\> 30 events/hr) (1).

Sleep quality before CABG

时间窗: Before operation, as soon as operation has scheduled

ESS, EPWORTH SLEEPINESS SCALE. All scores on the Epworth Sleepiness Scale fall between 0 and 24. Scores from 0 to 10 reflect normal levels of daytime sleepiness, and scores over 10 are considered to reflect excessive daytime sleepiness.

A transthoracic echocardiogram

时间窗: Before operation, as soon as operation has scheduled

Left ventricular end-diastolic diameter (LVEDD), Left ventricular end-systolic diameter (LVESD), Septal wall thickness (SWT), and Posterior wall thickness (PWT), Max/Min Diameter of IVC; all will be reported in cm.

次要结局

  • Sleep quality after CABG(After 6 to 8 months after surgery)
  • A transthoracic echocardiogram(After operation, 3-5 months after surgery)
  • Incidence of sleep disorders after coronary artery bypass surgery, polysomnography(After 6 to 8 months after surgery)

研究者

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

Marjo Ajosenpää

Principal Investigator

Turku University Hospital

研究点 (1)

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