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

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ClinicalTrials.gov Identifier: NCT03743090
Recruitment Status : Withdrawn (lack of PSG)
First Posted : November 15, 2018
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Eric DEFLANDRE, MD, PhD, FCCP, FAHA, 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.


Condition or disease Intervention/treatment
Coronary Artery Disease Diagnostic Test: Polysomnography.

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.

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Influence of Extracorporeal Circulation on the Development of OSA (Obstructive Sleep Apnea)
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : April 10, 2020

Resource links provided by the National Library of Medicine


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).




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All of the patients scheduled for an elective CABG at the Clinique Saint-Luc of Bouge (Namur, Belgium).
Criteria

Inclusion Criteria:

  • All of the patients scheduled for an elective CABG

Exclusion Criteria:

  • Patient's refusal

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03743090


Sponsors and Collaborators
Astes
Investigators
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Principal Investigator: Eric DEFLANDRE, MD, PhD Astes
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Responsible Party: Eric DEFLANDRE, MD, PhD, FCCP, FAHA, Head of Department, Astes
ClinicalTrials.gov Identifier: NCT03743090    
Other Study ID Numbers: OSACS
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eric DEFLANDRE, MD, PhD, FCCP, FAHA, Astes:
coronary artery disease
obstructive sleep apnea
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases