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Clinical Trials/NCT03743090
NCT03743090WithdrawnNot Applicable

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

Astes0 sitesStarted: August 1, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Sponsor
Primary Endpoint
Change in the AHI

Study Overview

Brief Summary

    1. Coronary artery bypass grafting (CABG) could be performed with or without extracorporeal circulation (ECC).
    1. OSA (Obstructive Sleep Apnea) could be influenced by in intravenous perfusion.
    1. 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).
    1. OSA (Obstructive Sleep Apnea) could be influenced by in intravenous perfusion.
    1. 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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • All of the patients scheduled for an elective CABG

Exclusion Criteria

  • Patient's refusal

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Astes
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Eric DEFLANDRE, MD, PhD, FCCP, FAHA

Head of Department

Astes

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