NCT03706859

Two Mathematical Methods to Estimate Arterial Occlusion Pressure and Tourniquet Effectiveness in Lower Limb Surgery

Completed NA Last updated 23 January 2019

What this trial tests

NA trial testing Pneumatic tourniquet inflation pressure in Vascular Diseases in 77 participants. Completed in 15 November 2018.

Timeline

12 May 2018

Primary endpoint
12 November 2018

15 November 2018

Quick facts

Lead sponsor	Beni-Suef University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	77
Start date	12 May 2018
Primary completion	12 November 2018
Estimated completion	15 November 2018
Sites	1 location across Egypt

Drugs / interventions tested

• Pneumatic tourniquet inflation pressure

Conditions studied

• Vascular Diseases — all drugs for Vascular Diseases →

Sponsor

Beni-Suef University

Who can join

Adults 18 to 40, any sex, with Vascular Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Pneumatic tourniquets are widely used not only to reduce blood loss and to ensure optimal operating conditions during extremity surgery, but also in regional anesthesia (local intravenous) vein puncture and to control life or limb threatening conditions. However, compression of the tissues under a tourniquet is associated with soft tissue damage involving the skin, vessels, muscles, and most importantly, nerves, and are commonly pressure related and can be affected by tourniquet time as well. Therefore, the "minimal tourniquet inflation pressure" necessary to provide a bloodless field has been suggested to minimize the risk of complications from excessive inflation pressure. Arterial occlusion pressure (AOP) is the lowest pneumatic tourniquet inflation pressure required to stop the arterial blood flow into the limb, and its usage has been shown to be useful in optimizing tourniquet cuff pressures. The pressure to which a pneumatic tourniquet cuff should be inflated depends on a number of variables, including the patient's age, skin, blood pressure and the shape and size of the extremity in question, as well as the dimensions of the cuff. One of the estimation method for AOP is based on systolic blood pressure (SBP) and tissue padding coefficient (KTP) values (AOP=\[SBP+10\]/KTP) according to extremity circumferences. Unver B. et al., used this method to estimate effective tourniquet pressure in total knee replacement under hypotensive general anesthesia tourniquet pressure achieved was 169.7±7.9 mmHg, while Tuncali et al., tested it again in different lower limb surgeries under general or neuraxial anesthesia with normotensive techniques and the achieved maximal tourniquet pressures used was 173.3±15.6 mmHg. Hong-yun Liu et al., established a new occlusion pressure mathematical model for the upper limb based on the correlation analysis between several possible influencing parameters and the minimal pneumatic tourniquet pressure.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Comparison between two mathematical methods to estimate arterial occlusion pressure and tourniquet effectiveness in lower limb surgery: a prospective, randomized, double blind, comparative study.
   Kasem SA, Al Menesy T, Badawy AA, Abd Elmawgoud A, et al · · 2020 · cited 4× · PMID 31346900 · DOI 10.1007/s10877-019-00366-0