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

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).

Study Overview

• Status: Completed
• Conditions: Ischemic Heart Disease; Coronary Artery Bypass Graft
• Intervention / Treatment: Procedure: Pneumatic tourniquet, endoscopic left radial artery harvesting

Detailed Description

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).

• Study Type: Observational
• Enrollment (Actual): 32

Contacts and Locations

Study Locations

• Egypt
  • DK
    • Mansoura, DK, Egypt, 050
      • Mansoura University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients who are listed for CABG surgery with the use of ERAH technique at cardiothoracic and vascular surgery center (Mansoura University Hospitals, Mansoura University) are eligible for this study.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
heart rate	HR will be recorded at inflating the tourniquet and every five minutes for thirty minutes. HR will be recorded at tourniquet deflation and every five minutes for total of thirty minutes.	the changes in HR are being assessed at baseline for 30 minutes and for 30 minutes of deflating the tourniquet.
systolic blood pressure	SBP will be recorded at inflating the tourniquet and every five minutes for thirty minutes. SBP will be recorded at tourniquet deflation and every five minutes for total of thirty minutes.	the changes in SBP are being assessed at baseline for 30 minutes and for 30 minutes of deflating the tourniquet.
diastolic blood pressure	DBP will be recorded at inflating the tourniquet and every five minutes for thirty minutes. DBP will be recorded at tourniquet deflation and every five minutes for total of thirty minutes.	the changes in DBP are being assessed at baseline for 30 minutes and for 30 minutes of deflating the tourniquet.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phenylephrine use	0 microgram of phenylephrine will be used after deflating the tourniquet if systolic blood pressure is lower than 100mmHg.	The phenylephrine use ( for SBP less than 100 mmHg) will be recorded for one hour

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Chair: Elsayed M Abdelkarime, MD, Lecturer of Anesthesia and Surgical Intensive care; Study Director: Ahmed A Eisa, MD, Lecturer of Anesthesia and Surgical Intensive care

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2022
• Primary Completion (Actual): July 30, 2022
• Study Completion (Actual): August 1, 2022

Study Registration Dates

• First Submitted: April 14, 2022
• First Submitted That Met QC Criteria: April 21, 2022
• First Posted (Actual): April 27, 2022

Study Record Updates

• Last Update Posted (Actual): August 5, 2022
• Last Update Submitted That Met QC Criteria: August 3, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia
• Other Study ID Numbers: MFM-IRB, R.22.02. 1615.R1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

The individual participant data will be available (including data dictionaries).

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared.

• IPD Sharing Time Frame: The data will be available immediately following publication and no end date.
• IPD Sharing Access Criteria: The data will be shared with anyone who wishes to access the data. To achieve the aims in the approved proposal. Data will be available indefinitely at my research gate account under the name (Elsayed Abdelkarime)
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No