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

NCT05349773 | Completed DMC

• 1 other identifier: MFM-IRB, R.22.02. 1615.R1
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Ischemic Heart Disease; Coronary Artery Bypass Graft

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Phenylephrine use

  The phenylephrine use ( for SBP less than 100 mmHg) will be recorded for one hour

Study Arms (1)

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

Interventions

Pneumatic tourniquet, endoscopic left radial artery harvesting 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.

endoscopic left radial artery harvesting

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Emergency CABG surgery.
• CABG plus any other cardiac surgery.
• The use of inopressor drugs before ERAH

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Al Mansurah, DK, 050, Egypt

Location

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Elsayed M Abdelkarime, MD

  Lecturer of Anesthesia and Surgical Intensive Care

  STUDY CHAIR

• Ahmed A Eisa, MD

  Lecturer of Anesthesia and Surgical Intensive Care

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2022
• First Posted: April 27, 2022
• Study Start: May 19, 2022
• Primary Completion: July 30, 2022
• Study Completion: August 1, 2022
• Last Updated: August 5, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: The data will be available immediately following publication and no end date.
• 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)

Locations

EG (1)