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

January 9, 2020 updated by: Eric DEFLANDRE, MD, PhD, FCCP, FAHA, Astes
  • 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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • All of the patients scheduled for an elective CABG

Exclusion Criteria:

  • Patient's refusal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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 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.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the AHI
Time Frame: 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.
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

August 1, 2019

Primary Completion (ANTICIPATED)

October 31, 2019

Study Completion (ANTICIPATED)

April 10, 2020

Study Registration Dates

First Submitted

November 13, 2018

First Submitted That Met QC Criteria

November 14, 2018

First Posted (ACTUAL)

November 15, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 13, 2020

Last Update Submitted That Met QC Criteria

January 9, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSACS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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