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Completed

NCT Number: NCT05349773

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).

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Key information

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mansoura University

Al Mansurah, DK, 050, Egypt

About this study

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).

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. heart rate

    Time frame: the changes in HR are being assessed at baseline for 30 minutes and for 30 minutes of deflating the tourniquet.

    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.

  2. systolic blood pressure

    Time frame: the changes in SBP are being assessed at baseline for 30 minutes and for 30 minutes of deflating the tourniquet.

    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.

  3. diastolic blood pressure

    Time frame: the changes in DBP are being assessed at baseline for 30 minutes and for 30 minutes of deflating the tourniquet.

    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.

Secondary outcomes

  1. Phenylephrine use

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

    0 microgram of phenylephrine will be used after deflating the tourniquet if systolic blood pressure is lower than 100mmHg.

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 27, 2022
Registry last updated
Aug 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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