The Pneumatic Tourniquet Technique for Endoscopic Radial Artery Harvest; Does it Affect Patient Hemodynamics?

NCT ID: NCT05349773

Last Updated: 2022-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-19

Study Completion Date

2022-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study aims to investigate the effect of the pneumatic tourniquet technique on the patients' hemodynamics; heart rate (HR), systolic blood pressure (SBP) and diastolic blood pressure (DBP).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Coronary artery bypass graft surgery (CABG) is the most common cardiac surgical procedure. Radial artery of the non-dominant hand with better ulnar collaterals is preferred over the saphenous vein because of long term patency of the radial artery. Radial artery is the preferred second or third arterial conduits for vessels with sub occlusive stenosis.

There are two techniques of radial artery harvesting; open and endoscopic techniques. Endoscopic radial artery harvesting (ERAH) is increasing and it is possible but the evidence regarding its safety is scarce. ERAH is cosmetically better than the open technique.

ERAH technique is performed after applying a tourniquet over the distal arm proximally to the elbow. Allen test will be done first and if the hand has a good blood supply through the ulnar artery, the tourniquet pressure is increased 75-100 mmHg over the systolic pressure and the tourniquet time is kept under one hour and the left radial artery will be endoscopically harvested.

During the time of tourniquet inflation, there is ischemia of the forearm with subsequent cellular ischemic changes like; cellular acidosis, cellular edema, and activation of cellular apoptosis. On deflating the tourniquet, there is reperfusion of the limb and development of ischemic / reperfusion injury with a subsequent increase of inflammatory mediators and reactive oxygen species (ROS). These changes may be associated with some hemodynamic instability that might be dangerous, especially in patients with ischemic heart disease (IHD).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ischemic Heart Disease Coronary Artery Bypass Graft

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

endoscopic left radial artery harvesting

single group of 32 patients listed for coronary artery bypass surgery with endoscopic radial artery harvesting.

Pneumatic tourniquet, endoscopic left radial artery harvesting

Intervention Type PROCEDURE

Endoscopic radial artery harvesting technique is performed after applying a tourniquet over the distal arm proximally to the elbow. The tourniquet pressure is increased 90 mmHg over the systolic pressure and the tourniquet time will be monitored.

he changes in Heart rate (HR), systolic blood pressure (SBP) and diastolic blood pressure (DBP) will be assessed before and after deflating the tourniquet every 5 minutes for 30 minutes.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pneumatic tourniquet, endoscopic left radial artery harvesting

Endoscopic radial artery harvesting technique is performed after applying a tourniquet over the distal arm proximally to the elbow. The tourniquet pressure is increased 90 mmHg over the systolic pressure and the tourniquet time will be monitored.

he changes in Heart rate (HR), systolic blood pressure (SBP) and diastolic blood pressure (DBP) will be assessed before and after deflating the tourniquet every 5 minutes for 30 minutes.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Listed for CABG surgery with the use of ERAH technique.

Exclusion Criteria

* Emergency CABG surgery.
* CABG plus any other cardiac surgery.
* The use of inopressor drugs before ERAH
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mansoura University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Elsayed M Abdelkarime, MD

Role: STUDY_CHAIR

Lecturer of Anesthesia and Surgical Intensive Care

Ahmed A Eisa, MD

Role: STUDY_DIRECTOR

Lecturer of Anesthesia and Surgical Intensive Care

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mansoura University

Al Mansurah, DK, Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MFM-IRB, R.22.02. 1615.R1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Lower Tourniquet Pressure Study
NCT04994405 COMPLETED NA