Clinical trial NCT05349773: The Pneumatic Tourniquet Technique for Endoscopic Radial Artery Harvest; Does it Affect Patient Hemodynamics?
Official title: The Pneumatic Tourniquet Technique for Endoscopic Radial Artery Harvest; Does it Affect Patient Hemodynamics?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Heart Disease
Coronary Artery Bypass Graft
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2022-04-27
Enrollment: 32
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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).

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).

Eligibility criteria: 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

Primary outcomes:
measure: heart rate
timeFrame: the changes in HR are being assessed at baseline for 30 minutes and for 30 minutes of deflating the tourniquet.
measure: systolic blood pressure
timeFrame: the changes in SBP are being assessed at baseline for 30 minutes and for 30 minutes of deflating the tourniquet.
measure: diastolic blood pressure
timeFrame: the changes in DBP are being assessed at baseline for 30 minutes and for 30 minutes of deflating the tourniquet.
Secondary outcomes:
measure: Phenylephrine use
timeFrame: The phenylephrine use ( for SBP less than 100 mmHg) will be recorded for one hour
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
state: DK
Study officials:
affiliation: Lecturer of Anesthesia and Surgical Intensive Care
name: Elsayed M Abdelkarime, MD
role: STUDY_CHAIR
affiliation: Lecturer of Anesthesia and Surgical Intensive Care
name: Ahmed A Eisa, MD
role: STUDY_DIRECTOR
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