Effects of Different Compression Pressure Levels on Peripheral Circulation After Surgery (COMP-PILOT)

Agri Ibrahim Cecen University

Status: Begins enrollment this month

Conditions: Venous Hemodynamics; Peripheral Circulation; Postoperative Circulatory Changes

Treatments: Device: Pressure-Controlled Compression Device

Study type: Interventional

Funder types: Other

Identifiers

NCT07394829

AICU-COMP-POSTOP-2026

Details and patient eligibility

About

After surgery, elastic compression is commonly used on the legs to support blood circulation and reduce the risk of complications such as swelling and venous thromboembolism. In clinical practice, compression is usually applied at fixed pressure levels, although individual patients may respond differently depending on their circulation and tissue tolerance.

The purpose of this pilot study is to evaluate how different compression pressure levels affect peripheral circulation in adult patients during the early postoperative period. Participants will receive three different levels of leg compression applied sequentially under controlled conditions. Peripheral circulation will be assessed using non-invasive methods, including photoplethysmography and peripheral perfusion index measurements.

The findings of this study are expected to provide preliminary evidence on individual circulatory responses to different compression pressures and to support the development of more personalized postoperative compression strategies in future clinical practice.

Full description

Elastic compression therapy is a standard component of postoperative care aimed at improving venous return, reducing lower extremity edema, and supporting peripheral circulation. Despite its widespread use, compression is commonly applied using fixed pressure levels without systematic consideration of individual circulatory responses. This may result in suboptimal effectiveness or discomfort in some patients.

This study is designed as a prospective, single-center pilot interventional study to investigate the effects of different compression pressure levels on lower extremity peripheral circulation in adult postoperative patients. The study will be conducted in surgical wards of Ağrı Training and Research Hospital. Adult patients who have undergone elective surgery and are hemodynamically stable will be enrolled during the early postoperative period.

Each participant will receive three sequential compression pressure levels applied to the calf region using a pressure-controlled compression device. The predefined pressure levels are low (30 mmHg), moderate (45 mmHg), and high (60 mmHg). Compression will be applied in a supine position following a standardized rest period. Each pressure level will be maintained for a fixed duration, with adequate rest intervals between applications to allow circulation to return to baseline.

Peripheral circulation will be assessed at baseline and after each compression level using non-invasive measurement techniques. The primary outcome measures include peripheral perfusion index and venous filling time assessed by photoplethysmography. Secondary outcome measures include lower extremity edema, skin surface temperature, and patient-reported comfort assessed using a visual analog scale. Safety and tolerability will be monitored throughout the study, and compression will be discontinued immediately if any discomfort or adverse effects occur.

As a pilot study, the planned sample size is limited and no formal power calculation has been performed. The primary objective is to generate preliminary data on circulatory responses to different compression pressures and to evaluate the feasibility of the study protocol. The results are intended to inform the design of future larger-scale clinical trials and contribute to evidence-based, individualized postoperative compression practices.

The study will be conducted in accordance with the Declaration of Helsinki. Ethics committee approval was obtained prior to study initiation, and written informed consent will be obtained from all participants before enrollment.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Adult patients aged 18 to 65 years.

Patients who have undergone elective surgery and are in the early postoperative period.

Hemodynamically stable patients at the time of assessment.

Patients with intact skin at the lower extremities where compression will be applied.

Patients able to understand the study procedures and provide written informed consent.

Exclusion criteria

Presence of peripheral arterial disease or clinically significant arterial insufficiency.

Active or previous diagnosis of deep vein thrombosis or venous thromboembolism.

Known peripheral neuropathy or sensory impairment affecting the lower extremities.

Open wounds, active infection, or dermatological conditions on the lower extremities.

Severe edema requiring therapeutic intervention beyond standard postoperative care.

Inability to tolerate compression therapy due to pain or discomfort.

Pregnancy.

Participation in another interventional clinical study during the same hospitalization period.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Sequential Compression Pressure Intervention

Experimental group

Description:

All participants will receive sequential lower extremity compression at three predefined pressure levels (30 mmHg, 45 mmHg, and 60 mmHg) applied to the calf region during the early postoperative period, with repeated measurements at each pressure level within the same participant.

Treatment:

Device: Pressure-Controlled Compression Device