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RecruitingNCT06453538

Sleep Quality and Sleep-disordered Breathing in Bypass Surgery Patients

Status
Recruiting
Phase
Study type
Observational
Enrollment
54 (estimated)
Sponsor
Turku University Hospital · Other Government
Sex
All
Age
18 Years – 90 Years
Healthy volunteers
Not accepted

Summary

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

Detailed description

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).

Conditions

Timeline

Start date
2023-02-01
Primary completion
2025-12-30
Completion
2025-12-30
First posted
2024-06-11
Last updated
2024-06-26

Locations

1 site across 1 country: Finland

Source: ClinicalTrials.gov record NCT06453538. Inclusion in this directory is not an endorsement.