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

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

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Vascular Diseases; Venous Insufficiency of Leg; Postoperative Circulatory Changes
• Intervention / Treatment: Device: Pressure-Controlled Compression Device

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Merkez
    • Ağrı, Merkez, Turkey (Türkiye)
      • Ağrı Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults aged 18 to 65 years
• Undergoing elective surgery
• In the early postoperative period at the time of assessment
• Hemodynamically stable
• Intact skin on the lower extremities at the planned compression sites
• Able to understand the study procedures
• Willing and able to provide written informed consent

Exclusion Criteria:

• Peripheral arterial disease or clinically significant arterial insufficiency
• Current 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Sequential Compression Pressure Intervention; 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peripheral Perfusion Index (PPI)	Peripheral Perfusion Index (PPI) will be measured as a dimensionless numerical value using a non-invasive photoplethysmography-based monitoring device. PPI represents the ratio of pulsatile to non-pulsatile blood flow and serves as an objective indicator of peripheral microcirculatory perfusion. Measurements will be obtained at four predefined time points: baseline before compression (T0), after application of 30 mmHg compression (T1), after application of 45 mmHg compression (T2), and after application of 60 mmHg compression (T3). All measurements will be performed in the supine position following a standardized rest period of at least 10 minutes.	Baseline (T0) and during sequential compression applications (T1-T3) within the first 48 hours after surgery
Venous Filling Time Measured by Photoplethysmography (seconds)	Venous filling time will be measured in seconds (s) using non-invasive photoplethysmography to assess venous hemodynamic response of the lower extremity. Venous filling time reflects the rate of venous refilling following compression release. Measurements will be recorded at baseline (T0) and after each compression pressure level: 30 mmHg (T1), 45 mmHg (T2), and 60 mmHg (T3), using standardized sensor placement at the calf region in the supine position. .	Baseline (T0) and during sequential compression applications (T1-T3) within the first 48 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lower Extremity Edema (Circumference Measurement, cm)	Lower extremity edema will be assessed by circumferential tape measurements (centimeters) at standardized anatomical landmarks, including the ankle (malleolar level) and calf (maximum circumference), at baseline and after each compression pressure level.	Baseline (T0) and during sequential compression applications (T1-T3) within the first 48 hours after surgery
Skin Surface Temperature (°C)	Skin surface temperature of the lower extremity will be measured in degrees Celsius (°C) using non-invasive thermal sensors to assess peripheral thermal response associated with different compression pressure levels.	Baseline (T0) and during sequential compression applications (T1-T3) within the first 48 hours after surgery
Patient Comfort Assessed by Visual Analog Scale (VAS, 0-10)	Patient comfort and tolerance will be assessed using a Visual Analog Scale (VAS) ranging from 0 (no discomfort) to 10 (maximum discomfort). The VAS score will be recorded after each compression pressure level to evaluate subjective comfort during the intervention.	Baseline (T0) and during sequential compression applications (T1-T3) within the first 48 hours after surgery

Collaborators and Investigators

• Sponsor: Agri Ibrahim Cecen University

Publications and helpful links

General Publications

• Sun X, He H, Xu M, Long Y. Peripheral perfusion index of pulse oximetry in adult patients: a narrative review. Eur J Med Res. 2024 Sep 11;29(1):457. doi: 10.1186/s40001-024-02048-3.
• van Genderen ME,Paauwe J,de Jonge J,van der Valk RJ,Lima A,Bakker J,van Bommel J
• Ren W,Duan Y,Jan YK,Li J,Liu W,Pu F,Fan Y
• Agerskov M,Thusholdt ANW,Højlund J,Meyhoff CS,Sørensen H,Wiberg S,Secher NH,Bang Foss N
• Sun X,He H,Xu M,Long Y

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2026
• Primary Completion (Actual): April 1, 2026
• Study Completion (Actual): April 5, 2026

Study Registration Dates

• First Submitted: January 31, 2026
• First Submitted That Met QC Criteria: January 31, 2026
• First Posted (Actual): February 6, 2026

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 5, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Postoperative care; Pilot study; Peripheral perfusion index; Elastic compression; Compression pressure; Lower extremity circulation
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases
• Other Study ID Numbers: AICU-COMP-POSTOP-2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared due to the pilot nature of the study, the small sample size, and the single-center design. The collected data include detailed physiological measurements that could potentially increase the risk of participant re-identification. Aggregate and de-identified results will be reported in scientific publications in accordance with ethical approval and data protection regulations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No