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

NCT03706859 | Completed

• 1 other identifier: FM-BSU REC 005/2018
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vascular Diseases

Outcome Measures

Primary Outcomes (2)

• Systolic Blood Pressure,

  initial and maximal Systolic Blood Pressure,

  baseline and maximum inflation

• tourniquet inflation pressure.

  initial and maximum tourniquet inflation pressure.

  baseline and maximum inflation

Secondary Outcomes (1)

• surgeon rating of the bloodlessness of the surgical field.

  middle and end of surgery

Study Arms (2)

Tourniquet inflation pressure method 1

EXPERIMENTAL

the pneumatic tourniquet inflation pressure at 20 mmHg above the arterial occlusion pressure which will be estimated using the equation of Unver B. et al.,: (AOP=\[SBP+10\]/KTP)

Procedure: Pneumatic tourniquet inflation pressure

Tourniquet inflation pressure method 2

ACTIVE COMPARATOR

the pneumatic tourniquet inflateion pressure at 20 mmHg above the arterial occlusion pressure which will be estimated using the equation of Hong-yun Liu et al.,: (AOP = 17.986 + 3.158X1 + 0.408X2)

Procedure: Pneumatic tourniquet inflation pressure

Interventions

Pneumatic tourniquet inflation pressure PROCEDURE

Pneumatic tourniquet inflation pressure estimation using two different mathematical equations

Tourniquet inflation pressure method 1; Tourniquet inflation pressure method 2

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• adult patients 18-40 years old, (ASA I-II), scheduled for knee arthroscopy under general anesthesia with pneumatic tourniquet around the thigh,

You may not qualify if:

• outside the age range, hypertensive, diabetic, complaining of any lower limb claudications, any vascular disease, hemolytic blood disorders or hypercoagulabilty.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Beni Suef University, Faculty of medicine

Banī Suwayf, 62511, Egypt

Location

Related Publications (4)

• Unver B, Karatosun V, Tuncali B. Effects of tourniquet pressure on rehabilitation outcomes in patients undergoing total knee arthroplasty. Orthop Nurs. 2013 Jul-Aug;32(4):217-22. doi: 10.1097/NOR.0b013e31829aef2a.

  PMID: 23881019 BACKGROUND

• Liu HY, Guo JY, Zhang ZB, Li KY, Wang WD. Development of adaptive pneumatic tourniquet systems based on minimal inflation pressure for upper limb surgeries. Biomed Eng Online. 2013 Sep 23;12:92. doi: 10.1186/1475-925X-12-92.

  PMID: 24053348 BACKGROUND

• Tuncali B, Boya H, Kayhan Z, Arac S, Camurdan MA. Clinical utilization of arterial occlusion pressure estimation method in lower limb surgery: effectiveness of tourniquet pressures. Acta Orthop Traumatol Turc. 2016;50(2):171-7. doi: 10.3944/AOTT.2015.15.0175.

  PMID: 26969952 BACKGROUND

• Kasem SA, Al Menesy T, Badawy AA, Abd Elmawgoud A, Adel G, Badawy YA. Comparison between two mathematical methods to estimate arterial occlusion pressure and tourniquet effectiveness in lower limb surgery: a prospective, randomized, double blind, comparative study. J Clin Monit Comput. 2020 Aug;34(4):675-681. doi: 10.1007/s10877-019-00366-0. Epub 2019 Jul 25.

  PMID: 31346900 DERIVED

MeSH Terms

Conditions

Vascular Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: October 9, 2018
• First Posted: October 16, 2018
• Study Start: May 12, 2018
• Primary Completion: November 12, 2018
• Study Completion: November 15, 2018
• Last Updated: January 23, 2019

Record last verified: 2019-01

Locations

EG (1)