Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06453538
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-04-10
Brief Title:
Sleep Quality and Sleep-disordered Breathing in Bypass Surgery Patients
Sponsor:
Turku University Hospital
Organization:
Turku University Hospital
Study Overview
Official Title:
Sleep Quality and Sleep-disordered Breathing in Bypass Surgery Patients
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
UNI-CABG
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None