Pneumatic Tourniquet Application in Upper Extremity Surgeries

August 27, 2024 updated by: Sevgi Vermişli, Bursa City Hospital

Effect of Cuff Pressure Level and Protective Padding Material Selection on the Prevention of Skin Complications in Pneumatic Tourniquet Applications in Upper Extremity Surgery: Clinical Research

Purpose: This study investigated the effect of cuff pressure and the selection of protective padding material(PPM) on the prevention of skin complications associated with pneumatic tourniquet(PT) application in upper extremity surgery.

Methods: This randomized controlled trial was conducted between October 2022 and September 2023 at the Hand Surgery Clinic of XXX. Standard tourniquet pressure (STP) or limb occlusion pressure (LOP) was applied as PT cuff pressure. Cotton pads or elastic stockinette was used for PPM under the cuff. Patients were categorized into four groups; (i) STP with a cotton pad; (ii) STP with an elastic stockinette; (iii) LOP with a cotton pad; and (iv) LOP with an elastic stockinette. Total of 200 patients were included in the study, with 50 patients in each group. Skin complications were evaluated postoperatively at 0, 30, and 180 min.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Pneumatic tourniquet (PT) is frequently used in extremity surgeries because of its advantages, including better surgical field visibility and shorter operation duration. Notwithstanding its advantages, PT can cause a number complications in the postoperative period, including pain, edema, skin complications, muscle injuries, thromboembolism, and neurological damage. Although the risks associated with the use of PT have decreased because of the introduction of adjustable pressure mechanisms and safety alarm systems, complications can still occur. Surgical team members should be knowledgeable about PT to ensure quality and safe patient care. It is of great importance to evaluate the size and shape of the extremity and skin condition prior to PT application, apply the appropriate size cuff, and evaluate the skin under the cuff and peripheral pulses distal to the cuff upon application.

There are different recommendations regarding safety practices for the application of PT in extremity surgeries. Previous studies in the relevant literature reported controversial results regarding the appropriate tourniquet cuff pressure for extremity surgery, and there are different applications for determining the cuff pressure. Previous studies mostly used standard tourniquet pressure (STP). STP is defined as 250 mmHg pressure for the upper extremity and 300 mmHg pressure for the lower extremity. Nevertheless, minimum inflation pressures have been recommended instead of STP to prevent complications likely associated with high pressures. Another method is the use of limb occlusion pressure (LOP). LOP is defined as the minimum pressure required to stop arterial blood flow into the extremity distal to the cuff. LOP can be determined manually or automatically by slowly inflating the cuff and stopping the pulse using certain equipment, including a Doppler flowmeter or pulse oximeter. It was suggested that PT cuff pressure could be minimized by LOP application and that the risk of tourniquet-related complications could be reduced. Most previous studies on PT have focused on the lower extremities. Nevertheless, tourniquet use also been the method of choice in upper extremity surgery to provide a surgical field without blood.

In PT applications, protective padding material (PPM) is placed between the skin and the cuff to prevent skin injuries. The Association of Perioperative Registered Nurses recommends the application of soft, low-lint padding materials, including limb protection sleeves or two layers of stockinette (plaster stocking). The padding material should not compress the skin or cause wrinkles. Fewer skin complications were observed in patients with cotton pads or elastic stockinette than in patients without PPM. There is no material with proven superiority in the use of PPM.

This study investigated the effects of cuff pressure level and the choice of PPM on the prevention of skin complications after PT in upper extremity surgery. It was hypothesized that there was a relationship between the level of cuff pressure and the PPM during use and skin complications during PT applications in upper extremity surgery.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Bursa, Turkey
        • Republic of Turkey Ministry of Health Bursa City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients who 18 years and older
  • Patients who undergoing upper extremity surgery
  • Patients who underwent surgery under general and regional anesthesia
  • Patients who having no communication problems
  • Patients who agreeing to participate in the study

Exclusion Criteria:

  • Patients who with communication barriers
  • Patients who refused to participate in the study
  • Patients who aged below 18 years
  • Patients who underwent surgery for the second time
  • Patients who underwent bilateral extremity surgery
  • Patients without pneumatic tourniquet application
  • Patients who received hypertension treatment
  • Patients who diabetes mellitus treatment
  • Patients who had skin lesions under the cuff during preoperative observation
  • Patients who had active infection
  • Patients who had skin complications
  • Patients who have an above-elbow splint applied
  • Patients who underwent surgical operation associated with malignancy
  • Patients with the surgical area located proximal to the elbow

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard tourniquet pressure with cotton pad
Cotton pad was applied as protective filling material. Standard 250 mmHg pressure was applied as pneumatic tourniquet pressure.
Other: Standard tourniquet pressure (250 mmHg)
The effectiveness of the protective padding material placed on the skin with a pneumatic tourniquet cuff and the pneumatic tourniquet pressure determination methods were compared.
Other: Cotton Pad
The effectiveness of the protective padding material placed on the skin with a pneumatic tourniquet cuff and the pneumatic tourniquet pressure determination methods were compared.
Active Comparator: Standard tourniquet pressure with elastic stockinette
Elastic stockinette was applied as protective filling material. Standard 250 mmHg pressure was applied as pneumatic tourniquet pressure.
Other: Standard tourniquet pressure (250 mmHg)
The effectiveness of the protective padding material placed on the skin with a pneumatic tourniquet cuff and the pneumatic tourniquet pressure determination methods were compared.
Other: Elastic stockinette
The effectiveness of the protective padding material placed on the skin with a pneumatic tourniquet cuff and the pneumatic tourniquet pressure determination methods were compared.
Active Comparator: Limb occlusion pressure with cotton pad
Cotton pad was applied as protective filling material. Limb occlusion pressure was applied as pneumatic tourniquet pressure.
Other: Cotton Pad
The effectiveness of the protective padding material placed on the skin with a pneumatic tourniquet cuff and the pneumatic tourniquet pressure determination methods were compared.
Other: Limb occlusion pressure
The effectiveness of the protective padding material placed on the skin with a pneumatic tourniquet cuff and the pneumatic tourniquet pressure determination methods were compared.
Active Comparator: Limb occlusion pressure with elastic stockinette
Elastic stockinette was applied as protective filling material. Limb occlusion pressure was applied as pneumatic tourniquet pressure.
Other: Elastic stockinette
The effectiveness of the protective padding material placed on the skin with a pneumatic tourniquet cuff and the pneumatic tourniquet pressure determination methods were compared.
Other: Limb occlusion pressure
The effectiveness of the protective padding material placed on the skin with a pneumatic tourniquet cuff and the pneumatic tourniquet pressure determination methods were compared.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Redness
Time Frame: through study completion, an average of 1 year
Redness was defined as a reddish appearance on the skin, in contrast to a normal skin appearance.
through study completion, an average of 1 year
Tourniquet scar
Time Frame: through study completion, an average of 1 year
A tourniquet scar is a scar on the skin in the form of wrinkles and folds aligned with the structure of the sleeve.
through study completion, an average of 1 year
Petechiae
Time Frame: through study completion, an average of 1 year
Petechiae was defined as the occurrence of pinpoint-sized hemorrhages under the skin of the sleeve.
through study completion, an average of 1 year
Bulla
Time Frame: through study completion, an average of 1 year
A bulla is considered a fluid-filled blister on the skin.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bursa City Hospital

Investigators

  • Study Chair: Sevgi Vermisli Ciftci, Ph.D., Republic of Turkey Ministry of Health Bursa City Hospital/Operating Room
  • Principal Investigator: Zeki Gunsoy, M.D., Republic of Turkey Ministry of Health Bursa City Hospital/Hand Surgery Clinic
  • Principal Investigator: Fatma Demir Korkmaz, Professor, Ege University/ Faculty of Nursing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2022

Primary Completion (Actual)

July 30, 2023

Study Completion (Actual)

September 29, 2023

Study Registration Dates

First Submitted

August 22, 2024

First Submitted That Met QC Criteria

August 27, 2024

First Posted (Actual)

August 28, 2024

Study Record Updates

Last Update Posted (Actual)

August 28, 2024

Last Update Submitted That Met QC Criteria

August 27, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2022-12/5

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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