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Pneumatic Tourniquet Application in Upper Extremity Surgeries

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06575088
Enrollment
200
Registered
2024-08-28
Start date
2022-10-14
Completion date
2023-09-29
Last updated
2024-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complication of Surgical Procedure, Skin Wound

Keywords

Skin Complications, Protective Material, Pneumatic Tourniquet, Tourniquet Pressure, Upper Extremity Surgery

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.

Interventions

OTHERStandard 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.

OTHERLimb 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.

OTHERCotton 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.

OTHERElastic 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.

Sponsors

Bursa City Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Intervention model description

Patients were categorized into four groups based on the method of choice for determining the level of tourniquet cuff pressure and the PPM applied under the cuff. (i) . Standard tourniquet pressure (STP) with cotton pad; (ii) STP with elastic stockinette; (iii) limb occlusion pressure (LOP) with cotton pad; and finally, LOP with elastic stockinette. Power analysis was performed using the PASS software for sample size calculation. 50 patients were included in each group, considering that some patients might discontinue the trial. Block randomization method was used to randomize patients into study groups. The independent variables of the study were skin complications associated with tourniquet application on the skin under the sleeve. Complications were identified by the study team and confirmed by clinic nurses, and there was no disagreement regarding the occurrence of complications.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Rednessthrough study completion, an average of 1 yearRedness was defined as a reddish appearance on the skin, in contrast to a normal skin appearance.
Tourniquet scarthrough study completion, an average of 1 yearA tourniquet scar is a scar on the skin in the form of wrinkles and folds aligned with the structure of the sleeve.
Petechiaethrough study completion, an average of 1 yearPetechiae was defined as the occurrence of pinpoint-sized hemorrhages under the skin of the sleeve.
Bullathrough study completion, an average of 1 yearA bulla is considered a fluid-filled blister on the skin.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026