Postoperative Circulatory ChangesCOMP-PILOTNCT07394829
Effects of Different Compression Pressure Levels on Peripheral Circulation After Surgery
A study of Postoperative Circulatory Changes and Peripheral Vascular Diseases, run by Agri Ibrahim Cecen University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Circulatory Changes, Peripheral Vascular Diseases, Venous Insufficiency of Leg
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2026to 5 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ağrı Training and Research Hospital
Ağrı, Merkez
About this study
Official title: 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.
Read the 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
- Being tested
- Pressure-Controlled Compression Device
- Keywords
- Elastic compression, Compression pressure, Postoperative care, Peripheral perfusion index, Lower extremity circulation, Pilot study
- Medical subject headings
- Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressure-Controlled Compression DeviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Sequential Compression Pressure Intervention | Experimental | 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. Receives: Device: Pressure-Controlled Compression Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
.
Measured: Baseline (T0) and during sequential compression applications (T1-T3) within the first 48 hours after surgery
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline (T0) and during sequential compression applications (T1-T3) within the first 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start15 Feb 2026
- Primary completion1 Apr 2026
- Study completion5 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Postoperative Circulatory ChangesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will receive sequential compression pressure levels applied in a single group design, with repeated measurements at each pressure level within the same participant.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agri Ibrahim Cecen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Volkan Gokmen, Agri Ibrahim Cecen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07394829
- Sponsor's protocol ID
- AICU-COMP-POSTOP-2026
- Acronym
- COMP-PILOT
- Status last verified
- Apr 2026
- First submitted
- 31 Jan 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
van Genderen ME, Paauwe J, de Jonge J, van der Valk RJ, Lima A, Bakker J, van Bommel J. Clinical assessment of peripheral perfusion to predict postoperative complications after major abdominal surgery early: a prospective observational study in adults. Crit Care. 2014 Jun 3;18(3):R114. doi: 10.1186/cc13905.
PubMed 24894892Ren W, Duan Y, Jan YK, Li J, Liu W, Pu F, Fan Y. Effect of intermittent pneumatic compression with different inflation pressures on the distal microvascular responses of the foot in people with type 2 diabetes mellitus. Int Wound J. 2022 Aug;19(5):968-977. doi: 10.1111/iwj.13693. Epub 2021 Sep 15.
PubMed 34528370Agerskov M, Thusholdt ANW, Hojlund J, Meyhoff CS, Sorensen H, Wiberg S, Secher NH, Bang Foss N. Protocol for a multicentre retrospective observational cohort study in Denmark: association between the intraoperative peripheral perfusion index and postoperative morbidity and mortality in acute non-cardiac surgical patients. BMJ Open. 2019 Nov 21;9(11):e031249. doi: 10.1136/bmjopen-2019-031249.
PubMed 31753878Sun 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.
PubMed 39261939
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Different Compression Pressure Levels on Lower Extremity Peripheral Circulation in the Postoperative Period: A Pilot Study
- ClinicalTrials.gov ID
- NCT07394829
- Acronym / sponsor ID
- COMP-PILOT / AICU-COMP-POSTOP-2026
- Conditions
- Postoperative Circulatory Changes, Peripheral Vascular Diseases, Venous Insufficiency of Leg
- Keywords
- Elastic compression, Compression pressure, Postoperative care, Peripheral perfusion index, Lower extremity circulation, Pilot study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Agri Ibrahim Cecen UniversityUniversity, hospital or other
- Study start
- 15 Feb 2026 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 5 Apr 2026 (actual)
- First posted
- 6 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will receive sequential compression pressure levels applied in a single group design, with repeated measurements at each pressure level within the same participant.
| Arm | Type | Receives |
|---|---|---|
| Sequential Compression Pressure Intervention | Experimental | Device: Pressure-Controlled Compression DeviceAll 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pressure-Controlled Compression DeviceA 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. | Device | Sequential Compression Pressure Intervention |
Primary outcome
Peripheral Perfusion Index (PPI)
Time frame: Baseline (T0) and during sequential compression applications (T1-T3) within the first 48 hours after surgery
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.
Venous Filling Time Measured by Photoplethysmography (seconds)
Time frame: Baseline (T0) and during sequential compression applications (T1-T3) within the first 48 hours after surgery
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. .
3 secondary outcomes
Lower Extremity Edema (Circumference Measurement, cm)
Time frame: Baseline (T0) and during sequential compression applications (T1-T3) within the first 48 hours after surgery
Skin Surface Temperature (°C)
Time frame: 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)
Time frame: Baseline (T0) and during sequential compression applications (T1-T3) within the first 48 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Background: PubMed 24894892van Genderen ME, Paauwe J, de Jonge J, van der Valk RJ, Lima A, Bakker J, van Bommel J. Clinical assessment of peripheral perfusion to predict postoperative complications after major abdominal surgery early: a prospective observational study in adults. Crit Care. 2014 Jun 3;18(3):R114. doi: 10.1186/cc13905.
- Background: PubMed 34528370Ren W, Duan Y, Jan YK, Li J, Liu W, Pu F, Fan Y. Effect of intermittent pneumatic compression with different inflation pressures on the distal microvascular responses of the foot in people with type 2 diabetes mellitus. Int Wound J. 2022 Aug;19(5):968-977. doi: 10.1111/iwj.13693. Epub 2021 Sep 15.
- Background: PubMed 31753878Agerskov M, Thusholdt ANW, Hojlund J, Meyhoff CS, Sorensen H, Wiberg S, Secher NH, Bang Foss N. Protocol for a multicentre retrospective observational cohort study in Denmark: association between the intraoperative peripheral perfusion index and postoperative morbidity and mortality in acute non-cardiac surgical patients. BMJ Open. 2019 Nov 21;9(11):e031249. doi: 10.1136/bmjopen-2019-031249.
- Background: PubMed 39261939Sun 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Postoperative Circulatory Changes and Peripheral Vascular Diseases, run by Agri Ibrahim Cecen University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peripheral Perfusion Index (PPI) (time frame: Baseline (T0) and during sequential compression applications (T1-T3) within the first 48 hours after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07394829, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.