The Impact of Pericardial Closure on the Grafts, in the Context of Coronary Artery Bypass Grafting

Completed

• Conditions: Bypass Graft Stenosis
• Interventions: Other: Datas of Medistim machine

• Registration Number: NCT06181565
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

Once the pericardium is closed, there is no information on the hemodynamics of the grafts after coronary artery bypass grafting. This would be the reason for different opinions on pericardial closure: some teams do not close the pericardium and others close it.

In the department Cardiovascular Surgery of the University Hospital of Saint-Etienne, the Medistim machine is used in routine and the hemodynamic properties of the grafts are recorded immediately after the bypass surgery, before the closure of the pericardium.

Detailed Description

The aim of the study is to have hemodynamic information immediately after the closure of the pericardium using the Medistim machine. The prospective study will be conducted on 50 patients, who will be selected consecutively without randomization. The inclusion and exclusion criteria are determined.

Study Timeline

• Study Start: 2022-01-01
• Primary Completion: 2022-10-24
• Study Completion: 2022-10-24
• Status Verified: 2023-11
• Study First Submitted: 2023-11-23
• Study First Submitted QC: 2023-12-20
• Last Update Submitted: 2023-12-20
• Study First Posted: 2023-12-26
• Last Update Posted: 2023-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• All patients who will have isolated aortocoronary bypass grafting surgery

Exclusion Criteria

• History of thoracic trauma
• Severe cyphosis
• Severe thoracic deformity (Pectus excavatum)
• Pericardial disease
• History of radiotherapy
• Severe pulmonary disease (emphysema)
• Right heart failure
• Redo surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients who will have isolated aortocoronary bypass grafting surgery	Datas of Medistim machine	Patients who will have isolated aortocoronary bypass grafting surgery will be included. The Medistim machine will be use before and after pericardial closure. Datas will be collected and analysis.

Primary Outcome Measures

Name	Time	Method
Flow through the grafts	Minute : 1, 15	Datas will be collected by Medistim machine.

Secondary Outcome Measures

Name	Time	Method
Systolic curves	Minute : 1, 15	Datas will be collected by Medistim machine.
Pulsatility of the grafts	Minute : 1, 15	Datas will be collected by Medistim machine.
Diastolic curves	Minute : 1, 15	Datas will be collected by Medistim machine.
Resistance on grafts	Minute : 1, 15	Datas will be collected by Medistim machine.

Trial Locations

Locations (1)

Chu Saint-Etienne; 🇫🇷 Saint-Étienne, France