Influence of Extracorporeal Circulation on the Development of OSA (Obstructive Sleep Apnea)

Withdrawn

• Conditions: Coronary Artery Disease
• Interventions: Diagnostic Test: Polysomnography.

• Registration Number: NCT03743090
• Lead Sponsor: Astes

Brief Summary

* 1. Coronary artery bypass grafting (CABG) could be performed with or without extracorporeal circulation (ECC).

* 2. OSA (Obstructive Sleep Apnea) could be influenced by in intravenous perfusion.

* 3. ECC could influence the amount of intravenous perfusion administered to the patient.

The aim of this study was to examine the influence of ECC on the development of OSA.

Detailed Description

* 1. Coronary artery bypass grafting (CABG) could be performed with or without extracorporeal circulation (ECC).

* 2. OSA (Obstructive Sleep Apnea) could be influenced by in intravenous perfusion.

* 3. ECC could influence the amount of intravenous perfusion administered to the patient.

The aim of this study was to examine the influence of ECC on the development of OSA. The AHI (Apnea Hypopnea Index) will be used to assess this potential influence.

Study Timeline

• Study First Submitted: 2018-11-13
• Study First Submitted QC: 2018-11-14
• Study First Posted: 2018-11-15
• Study Start: 2019-08-01
• Primary Completion: 2019-10-31
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-09
• Last Update Posted: 2020-01-13
• Study Completion: 2020-04-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• All of the patients scheduled for an elective CABG

Exclusion Criteria

• Patient's refusal

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CABG without ECC	Polysomnography.	Group of patients for whom CABG was performed without ECC. A polysomnography will be performed to all of these patients the day before surgery and the third postoperative day.
CABG with ECC	Polysomnography.	Group of patients for whom CABG was performed under ECC. A polysomnography will be performed to all of these patients the day before surgery and the third postoperative day.

Primary Outcome Measures

Name	Time	Method
Change in the AHI	3 days	Change from baseline AHI (Apnea Hypopnea Index, which is the average amount of apnea and hypopnea per four of sleep) at the 3rd postoperative day. The AHI is derived from the polysomnography which will be performed to all of the patients the day before surgery and the 3rd postoperative day.