NCT07394829

Effects of Different Compression Pressure Levels on Peripheral Circulation After Surgery

Evaluation of the Effects of Different Compression Pressure Levels on Lower Extremity Peripheral Circulation in the Postoperative Period: A Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Agri Ibrahim Cecen University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Postoperative Circulatory Changes
• Peripheral Vascular Diseases
• Venous Insufficiency of Leg

Interventions

Type	Name	Description
DEVICE	Pressure-Controlled Compression Device	A pressure-controlled compression device will be applied to the calf region to deliver sequential compression at three predefined pressure levels: low (30 mmHg), moderate (45 mmHg), and high (60 mmHg). Each pressure level will be applied for a fixed duration with rest periods between applications to allow peripheral circulation to return to baseline. Compression will be performed in the supine position during the early postoperative period.

Timeline

• Start date: 2026-02-15
• Primary completion: 2026-04-01
• Completion: 2026-04-05
• First posted: 2026-02-06
• Last updated: 2026-04-09

Locations

1 site across 1 country: Turkey (Türkiye)