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

NCT03743090 | Withdrawn

• 1 other identifier: OSACS
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coronary Artery Disease

Keywords

coronary artery disease; obstructive sleep apnea

Outcome Measures

Primary Outcomes (1)

• Change in the AHI

  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.

  3 days

Study Arms (2)

CABG with ECC

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.

Diagnostic Test: Polysomnography.

CABG without ECC

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.

Diagnostic Test: Polysomnography.

Interventions

Polysomnography. DIAGNOSTIC_TEST

A polysomnography will be performed for all of the patients the day before surgery (value of reference), and on the second postoperative day (in order to examine the influence of ECC on the development of OSA).

CABG with ECC; CABG without ECC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All of the patients scheduled for an elective CABG at the Clinique Saint-Luc of Bouge (Namur, Belgium).

You may qualify if:

• All of the patients scheduled for an elective CABG

You may not qualify if:

• Patient's refusal

Sponsors & Collaborators

• Astes: lead

MeSH Terms

Conditions

Coronary Artery Disease; Sleep Apnea, Obstructive

Interventions

Polysomnography

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Eric DEFLANDRE, MD, PhD

  Astes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department

Study Record Dates

• First Submitted: November 13, 2018
• First Posted: November 15, 2018
• Study Start: August 1, 2019
• Primary Completion: October 31, 2019
• Study Completion: April 10, 2020
• Last Updated: January 13, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share