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NCT03743090 Clinical Trial

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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT03743090
Other study ID # OSACS
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date August 1, 2019
Est. completion date April 10, 2020

Study information
Verified date January 2020
Source Astes
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date April 10, 2020
Est. primary completion date October 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- All of the patients scheduled for an elective CABG

Exclusion Criteria:

- Patient's refusal

Study Design

Related Conditions & MeSH terms

Intervention

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).

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Astes

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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