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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03706859
Recruitment Status : Completed
First Posted : October 16, 2018
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Samaa A. Kasem, Beni-Suef University

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.

Condition or disease Intervention/treatment Phase
Vascular Diseases Procedure: Pneumatic tourniquet inflation pressure Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison Between Two Mathematical Methods to Estimate Arterial Occlusion Pressure and Tourniquet Effectiveness in Lower Limb Surgery: Randomized Comparative Study
Actual Study Start Date : May 12, 2018
Actual Primary Completion Date : November 12, 2018
Actual Study Completion Date : November 15, 2018

Arm Intervention/treatment
Experimental: Tourniquet inflation pressure method 1
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
Pneumatic tourniquet inflation pressure estimation using two different mathematical equations

Active Comparator: Tourniquet inflation pressure method 2
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
Pneumatic tourniquet inflation pressure estimation using two different mathematical equations




Primary Outcome Measures :
  1. Systolic Blood Pressure, [ Time Frame: baseline and maximum inflation ]
    initial and maximal Systolic Blood Pressure,

  2. tourniquet inflation pressure. [ Time Frame: baseline and maximum inflation ]
    initial and maximum tourniquet inflation pressure.


Secondary Outcome Measures :
  1. surgeon rating of the bloodlessness of the surgical field. [ Time Frame: middle and end of surgery ]
    surgeon rating of the bloodlessness of the surgical field.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03706859


Locations
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Egypt
Beni Suef University, Faculty of medicine
Banī Suwayf, Egypt, 62511
Sponsors and Collaborators
Beni-Suef University
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Samaa A. Kasem, Associate professor, Beni-Suef University
ClinicalTrials.gov Identifier: NCT03706859    
Other Study ID Numbers: FM-BSU REC 005/2018
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases