Clinical trial NCT06453538: Sleep Quality and Sleep-disordered Breathing in Bypass Surgery Patients
Official title: Sleep Quality and Sleep-disordered Breathing in Bypass Surgery Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sleep Disorder
Coronary Artery Disease
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2024-06-11
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All scheduled volunteered coronary artery bypass patients in Turku University Hospital area

Brief 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).

Eligibility criteria: Inclusion Criteria:

Elective coronary artery bypass surgery

Exclusion Criteria:

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

Primary outcomes:
measure: Incidence of sleep disorders before coronary artery bypass surgery (CABG), polysomnography
timeFrame: Before operation, as soon as operation has scheduled
measure: Sleep quality before CABG
timeFrame: Before operation, as soon as operation has scheduled
measure: A transthoracic echocardiogram
timeFrame: Before operation, as soon as operation has scheduled
Secondary outcomes:
measure: Incidence of sleep disorders after coronary artery bypass surgery, polysomnography
timeFrame: After 6 to 8 months after surgery
measure: Sleep quality after CABG
timeFrame: After 6 to 8 months after surgery
measure: A transthoracic echocardiogram
timeFrame: After operation, 3-5 months after surgery
Other outcomes:
measure: New York Heart Association -classification (NYHA) status
timeFrame: Before operation
Locations:
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
affiliation: Turku University Hospital/Heart Center
name: Nea Kalleinen, millä Associate Professor
role: STUDY_DIRECTOR
References: