Pneumatic Leg Compression and Norepinephrine Requirements in Patients Having Non-cardiac Surgery (PLANE)

August 22, 2026 updated by: Universitätsklinikum Hamburg-Eppendorf

Pneumatic Leg Compression and Norepinephrine Requirements in Patients Having Non-cardiac Surgery: a Pilot Monocentric Prospective Randomized Interventional Clinical Trial

The PLANE trial is a randomized, single-center trial investigating whether pneumatic leg compression reduces the amount of norepinephrine needed to keep MAP above 65mmHg compared to routine care without PLC in patients having non-cardiac surgery under general anesthesia

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

238

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Free and Hanseatic City of Hamburg
      • Hamburg, Free and Hanseatic City of Hamburg, Germany, 20246
        • University Medical Center Hamburg-Eppendorf

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Consenting patients ≥45 years scheduled for elective non-cardiac surgery under general anesthesia that is expected to last ≥60 minutes

Exclusion Criteria:

Patients with the following exclusion criteria:

  • high risk surgery according to the 2022 ESC guideline "Guidelines on cardiovascular assessment and management of patients undergoing non-cardiac surgery"
  • Surgery in which pneumatic calve compression is indicated according to ERAS guidelines
  • Surgery which interferes with the installation or correct function of PLC
  • Sepsis (according to current Sepsis-3 definition)
  • Pregnancy
  • Congestive heart failure NYHA III/IV
  • American Society of Anesthesiologists (ASA) physical status classification V or VI
  • Interference of PLC and patient positioning (e.g.; extreme Trendelenburg positioning, lithotomy positioning)
  • Contraindications for the use of PLC according to the German guideline13 (e.g., extensive thrombophlebitis, thrombosis or suspected thrombosis of the lower limbs, erysipelas, acute phlegmon, limb compartment syndrome, severe uncontrolled arterial hypertension, lymphatic drainage disorder proximal to PLC, extensive open soft tissue trauma, autoimmune blistering skin conditions such as IgA bullous dermatosis or bullous pemphigoid)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pneumatic leg compression

PLC group (i.e., intervention group):

Patients assigned to the PLC group will receive a pneumatic lower limb compression sleeve during surgery.
Device: Pneumatic leg compression
Patients assigned to the PLC group will receive a pneumatic leg compression sleeve encompassing the calf and thigh, with sleeve size adjusted according to thigh circumference and manufacturer recommendations. The compression pump will be activated before the start of surgery. After surgery, the responsible trial personnel will deactivate the pump and remove the compression sleeves in the PLC group. There will be no standardized anesthesia management protocol; all decisions regarding hemodynamic management will be made at the discretion of the treating anesthesiologist
No Intervention: Routine care

Routine care group (i.e., control group):

Patients assigned to the Routine care group will not receive a pneumatic lower limb compression sleeve. There will be no standardized anesthesia management protocol; all decisions regarding hemodynamic management will be made at the discretion of the treating anesthesiologist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average norepinephrine infusion rate
Time Frame: Intraoperative
Average intraoperative norepinephrine infusion rate [μg kg-1 min-1] needed to keep MAP above 65mmHg. The average intraoperative norepinephrine infusion rate will be calculated using the absolute amount of norepinephrine administered per kg bodyweight [μg kg-1] divided by the duration of surgery (between surgical incision and suture) [min] (continuous outcome)
Intraoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lowest intraoperative MAP [mmHg]
Time Frame: Intraoperative
Lowest intraoperative MAP [mmHg]
Intraoperative
Cumulative intraoperative time with MAP <65 mmHg [min]
Time Frame: Intraoperative
Cumulative intraoperative time with MAP <65 mmHg [min]
Intraoperative
Intraoperative area under a MAP of 65 mmHg
Time Frame: Intraoperative
Intraoperative area under a MAP of 65 mmHg
Intraoperative
Intraoperative time-weighted average MAP <65 mmHg (area under a MAP of 65 mmHg divided by the monitoring time)
Time Frame: Intraoperative
Intraoperative time-weighted average MAP <65 mmHg (area under a MAP of 65 mmHg divided by the monitoring time)
Intraoperative
Volume of crystalloid fluid given during surgery [ml]
Time Frame: Intraoperative
Volume of crystalloid fluid given during surgery [ml]
Intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 19, 2025

Primary Completion (Actual)

December 16, 2025

Study Completion (Actual)

December 16, 2025

Study Registration Dates

First Submitted

April 21, 2025

First Submitted That Met QC Criteria

April 21, 2025

First Posted (Actual)

April 30, 2025

Study Record Updates

Last Update Posted (Actual)

August 26, 2026

Last Update Submitted That Met QC Criteria

August 22, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-101383-BO-ff

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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