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Pneumatic Tourniquet Application in Upper Extremity Surgeries

Not Applicable
Completed
Conditions
Skin Wound
Complication of Surgical Procedure
Interventions
Other: Standard tourniquet pressure (250 mmHg)
Other: Limb occlusion pressure
Other: Cotton Pad
Other: Elastic stockinette
Registration Number
NCT06575088
Lead Sponsor
Bursa City Hospital
Brief Summary

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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
200
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Standard tourniquet pressure with cotton padCotton PadCotton pad was applied as protective filling material. Standard 250 mmHg pressure was applied as pneumatic tourniquet pressure.
Standard tourniquet pressure with cotton padStandard tourniquet pressure (250 mmHg)Cotton pad was applied as protective filling material. Standard 250 mmHg pressure was applied as pneumatic tourniquet pressure.
Standard tourniquet pressure with elastic stockinetteElastic stockinetteElastic stockinette was applied as protective filling material. Standard 250 mmHg pressure was applied as pneumatic tourniquet pressure.
Limb occlusion pressure with cotton padLimb occlusion pressureCotton pad was applied as protective filling material. Limb occlusion pressure was applied as pneumatic tourniquet pressure.
Standard tourniquet pressure with elastic stockinetteStandard tourniquet pressure (250 mmHg)Elastic stockinette was applied as protective filling material. Standard 250 mmHg pressure was applied as pneumatic tourniquet pressure.
Limb occlusion pressure with cotton padCotton PadCotton pad was applied as protective filling material. Limb occlusion pressure was applied as pneumatic tourniquet pressure.
Limb occlusion pressure with elastic stockinetteLimb occlusion pressureElastic stockinette was applied as protective filling material. Limb occlusion pressure was applied as pneumatic tourniquet pressure.
Limb occlusion pressure with elastic stockinetteElastic stockinetteElastic stockinette was applied as protective filling material. Limb occlusion pressure was applied as pneumatic tourniquet pressure.
Primary Outcome Measures
NameTimeMethod
Petechiaethrough study completion, an average of 1 year

Petechiae was defined as the occurrence of pinpoint-sized hemorrhages under the skin of the sleeve.

Bullathrough study completion, an average of 1 year

A bulla is considered a fluid-filled blister on the skin.

Tourniquet scarthrough 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.

Rednessthrough study completion, an average of 1 year

Redness was defined as a reddish appearance on the skin, in contrast to a normal skin appearance.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Republic of Turkey Ministry of Health Bursa City Hospital

🇹🇷

Bursa, Turkey

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