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Evaluation of Ischemia and Reperfusion Interval With Neuromonitorization in Tourniquet Application

Primary Purpose

Quadriceps Muscle Atrophy, Tourniquet, EMG

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Surgical tourniquet pressure selection
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Quadriceps Muscle Atrophy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Operation planning in the foot and ankle area Exclusion Criteria: Having a history of previous foot and ankle surgery, Having a history of previous knee surgery or spinal surgery, Diagnosis of diabetes mellitus, Having a known diagnosis of a disease affecting the peripheral nervous system (peripheral neuropathy, previous spinal surgery, stroke, etc.), Having a diagnosis of a disease affecting the known peripheral vascular system (Peripheral vascular disease, calcified popliteal artery, peripheral arterial bypass surgery, vasculitis, advanced chronic venous insufficiency), Having a disease that affects the ideal tourniquet application (Chronic Lymphedema, BMI>35, Stage 3 and above chronic renal failure, uncontrollable hypertension), Having been diagnosed with a known coagulation disorder, History of pulmonary embolism or deep vein thrombosis. ASA score above 3 Surgery time to be less than 80 minutes

Sites / Locations

  • Department of Orthopaedics and Traumatology, Istanbul University, Istanbul, TurkeyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

LOP + 50 mmHg

LOP + 100 mmHg

Arm Description

As a result of randomization, the surgical tourniquet pressure is 50 mmHg higher than the limb occlusion pressure. Limb occlusion pressure is calculated using the formulation by Graham: LOP = [(Systolic Pressure - Diastolic Pressure)× (Limb Diameter) / 3 Cuff Width)] + Diastolic Pressure

As a result of randomization, the surgical tourniquet pressure is 100 mmHg higher than the limb occlusion pressure. Limb occlusion pressure is calculated using the formulation by Graham: LOP = [(Systolic Pressure - Diastolic Pressure)× (Limb Diameter) / 3 Cuff Width)] + Diastolic Pressure

Outcomes

Primary Outcome Measures

MEP 50% reduction in intraoperative neuromonitorization
Time with more than 50% reduction in perioperative MEP will be compared in groups in which two different tourniquet pressures were applied.
MEP full recovery intraoperative neuromonitorization
Time with full recovery in perioperative MEP will be compared in groups in which two different tourniquet pressures were applied.

Secondary Outcome Measures

Quadriceps Tendon Thickness-USG
In the study, quadriceps tendon thickness measurements will be performed in B Mode using the Clarius Portable L7 HD3 Linear Ultrasound device (13-4 MHz).The measurements of the patients will be performed in the supine position with the knee flexed to 30 degrees with a pillow placed in the popliteal web to prevent anisotropy in the quadriceps. The USG probe will be parallel to the long axis of the femur in the sagittal plane, and the patella will be placed at the midpoint of the proximal pole with its distal part. Quadiceps tendon thickness was measured at three different levels, 5-10-15 mm from the proximal patella. The quadriceps tendon borders were determined as the first hyperechoic region, superficial and deep.
Quadriceps Tendon Thickness-MRI
In the study, the thickness of the quadriceps tendon will also be evaluated with MRI. In the sagittal T1 sequence of knee MRI images, the portion with the largest diameter 1.5 and 3 cm proximal to the superior pole of the patella will be taken as the tendon thickness.
Thigh Diameter
Thigh diameters were measured comparatively with a non-flexible 7 mm tape measure from 10 cm proximal to the midpoint of the proximal patella. As the leg length, the distance from the level of the tibial plateau to the medial malleolus type was measured.
Total Blood Estimate Volume Loss
Total blood volume will be calculated with the formula Nadler previously presented in the literature. Total blood volume loss will be calculated using preoperative and postoperative hemogram and hematocrit parameters.
CK levels
Creatinine kinase, one of the blood parameters showing muscle degradation, will be evaluated by taking blood samples from the patients before and after the surgery.
EMG
ENMG is an electrophysiological study often used to evaluate nerve injuries. Permanent nerve damage will be evaluated with a nerve conduction study performed by an experienced neurologist comparing both extremities at the first postoperative month of the participants. Peroneal and tibial nerves as motor nerves, sural and s.peroneal nerves as sensory nerves will be evaluated. The latency, amplitude and nerve conduction velocities of the nerves will be compared.
Surgical Area Pain
The pain of the surgical area will be evaluated over the VAS score.

Full Information

First Posted
May 7, 2023
Last Updated
June 21, 2023
Sponsor
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT05926154
Brief Title
Evaluation of Ischemia and Reperfusion Interval With Neuromonitorization in Tourniquet Application
Official Title
Evaluation of Ischemia and Reperfusion Interval With Neuromonitorization in Tourniquet Application
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this clinical trial is to compare two differential tourniquet pressure in lower extremity surgery cases. The main questions it aims to answer are: What are the perioperative neurophysiological effects of ischemia and compression in the tissue under the tourniquet? Are the effects of two different tourniquet pressures on neuromonitoring significantly different? Can the ideal time of the reperfusion interval be evaluated by neuromonitoring? Are the effects of two different tourniquet pressures on the quadriceps denervation significantly different from each other? Participants meeting the inclusion criteria will be evaluated for parameters to be used preoperatively. It will be evaluated in the 1st day, 1st week and 1-month follow-ups in the postoperative period. The investigators will compare two different tourniquet pressure ( Limb occlusion pressure +50 mmHg / + 100 mmHg) to see if it will be evaluated whether there is a significant difference in terms of quadriceps denervation, vas scores, total blood estimate volume loss, intraoperative MEP decrease, and recovery times, quadriceps tendon thickness, thigh circumfrences.
Detailed Description
As a result of the power analysis for this study, the number of samples was determined as 24. The study was started after the approval of the ethics committee. Participants who met the inclusion and exclusion criteria were randomized in terms of tourniquet pressure to be applied and divided into two groups. It was planned to evaluate quadriceps tendon thickness by USG and MRI, thigh circumference, VAS scores, CBC, and CK in blood samples in the preoperative period of all patients. It was planned to obtain parameters related to MEP by using intraoperative neuromonitorization during the surgery. In the postoperative period, all parameters that were evaluated preoperatively on the 1st day, 1st week, and 1st month were re-evaluated. Finally, EMG evaluation was planned for 1 month.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Quadriceps Muscle Atrophy, Tourniquet, EMG

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LOP + 50 mmHg
Arm Type
Experimental
Arm Description
As a result of randomization, the surgical tourniquet pressure is 50 mmHg higher than the limb occlusion pressure. Limb occlusion pressure is calculated using the formulation by Graham: LOP = [(Systolic Pressure - Diastolic Pressure)× (Limb Diameter) / 3 Cuff Width)] + Diastolic Pressure
Arm Title
LOP + 100 mmHg
Arm Type
Experimental
Arm Description
As a result of randomization, the surgical tourniquet pressure is 100 mmHg higher than the limb occlusion pressure. Limb occlusion pressure is calculated using the formulation by Graham: LOP = [(Systolic Pressure - Diastolic Pressure)× (Limb Diameter) / 3 Cuff Width)] + Diastolic Pressure
Intervention Type
Procedure
Intervention Name(s)
Surgical tourniquet pressure selection
Intervention Description
Limb occlusion pressure is calculated using the formulation by Graham: LOP = [(Systolic Pressure - Diastolic Pressure)× (Limb Diameter) / 3 Cuff Width)] + Diastolic Pressure. One group is LOP + 50 mm Hg and other one is LOP + 100 mmHg
Primary Outcome Measure Information:
Title
MEP 50% reduction in intraoperative neuromonitorization
Description
Time with more than 50% reduction in perioperative MEP will be compared in groups in which two different tourniquet pressures were applied.
Time Frame
Intraoperative
Title
MEP full recovery intraoperative neuromonitorization
Description
Time with full recovery in perioperative MEP will be compared in groups in which two different tourniquet pressures were applied.
Time Frame
Intraoperative
Secondary Outcome Measure Information:
Title
Quadriceps Tendon Thickness-USG
Description
In the study, quadriceps tendon thickness measurements will be performed in B Mode using the Clarius Portable L7 HD3 Linear Ultrasound device (13-4 MHz).The measurements of the patients will be performed in the supine position with the knee flexed to 30 degrees with a pillow placed in the popliteal web to prevent anisotropy in the quadriceps. The USG probe will be parallel to the long axis of the femur in the sagittal plane, and the patella will be placed at the midpoint of the proximal pole with its distal part. Quadiceps tendon thickness was measured at three different levels, 5-10-15 mm from the proximal patella. The quadriceps tendon borders were determined as the first hyperechoic region, superficial and deep.
Time Frame
Preoperative, Postoperative 1st day and 4th week will be evaluated
Title
Quadriceps Tendon Thickness-MRI
Description
In the study, the thickness of the quadriceps tendon will also be evaluated with MRI. In the sagittal T1 sequence of knee MRI images, the portion with the largest diameter 1.5 and 3 cm proximal to the superior pole of the patella will be taken as the tendon thickness.
Time Frame
Preoperative, Postoperative third month
Title
Thigh Diameter
Description
Thigh diameters were measured comparatively with a non-flexible 7 mm tape measure from 10 cm proximal to the midpoint of the proximal patella. As the leg length, the distance from the level of the tibial plateau to the medial malleolus type was measured.
Time Frame
Preoperative, Postoperative 1st day, first week and 4th week will be evaluated
Title
Total Blood Estimate Volume Loss
Description
Total blood volume will be calculated with the formula Nadler previously presented in the literature. Total blood volume loss will be calculated using preoperative and postoperative hemogram and hematocrit parameters.
Time Frame
Preoperative, Postoperative 1st day
Title
CK levels
Description
Creatinine kinase, one of the blood parameters showing muscle degradation, will be evaluated by taking blood samples from the patients before and after the surgery.
Time Frame
Preoperative, Postoperative 1st day, Postoperative 1 st month
Title
EMG
Description
ENMG is an electrophysiological study often used to evaluate nerve injuries. Permanent nerve damage will be evaluated with a nerve conduction study performed by an experienced neurologist comparing both extremities at the first postoperative month of the participants. Peroneal and tibial nerves as motor nerves, sural and s.peroneal nerves as sensory nerves will be evaluated. The latency, amplitude and nerve conduction velocities of the nerves will be compared.
Time Frame
Postoperative 1 st month
Title
Surgical Area Pain
Description
The pain of the surgical area will be evaluated over the VAS score.
Time Frame
Preoperative, Postoperative 1st day, Postoperative 1 st month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Operation planning in the foot and ankle area Exclusion Criteria: Having a history of previous foot and ankle surgery, Having a history of previous knee surgery or spinal surgery, Diagnosis of diabetes mellitus, Having a known diagnosis of a disease affecting the peripheral nervous system (peripheral neuropathy, previous spinal surgery, stroke, etc.), Having a diagnosis of a disease affecting the known peripheral vascular system (Peripheral vascular disease, calcified popliteal artery, peripheral arterial bypass surgery, vasculitis, advanced chronic venous insufficiency), Having a disease that affects the ideal tourniquet application (Chronic Lymphedema, BMI>35, Stage 3 and above chronic renal failure, uncontrollable hypertension), Having been diagnosed with a known coagulation disorder, History of pulmonary embolism or deep vein thrombosis. ASA score above 3 Surgery time to be less than 80 minutes
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmet Muçteba YILDIRIM, Asistant Dr
Phone
090 534 303 8472
Email
ahmet.yildirim.93@istanbul.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serkan BAYRAM, Ass. Prof.
Organizational Affiliation
Istanbul University Medicine Faculty Orthoapedic and Traumatology Department
Official's Role
Study Director
Facility Information:
Facility Name
Department of Orthopaedics and Traumatology, Istanbul University, Istanbul, Turkey
City
Istanbul
State/Province
Fatih-Topkapı
ZIP/Postal Code
34080
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmet M YILDIRIM, Assistant
Phone
090 212 414 2000
Ext
31516
Email
ahmet.yildirim.93@istanbul.edu.tr

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Ischemia and Reperfusion Interval With Neuromonitorization in Tourniquet Application

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