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

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: Hypotension During Surgery
• Intervention / Treatment: Device: Pneumatic leg compression

• Study Type: Interventional
• Enrollment (Actual): 238
• Phase: Not Applicable

Contacts and Locations

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

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:

• 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

How is the study designed?

Design Details

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

Number of Arms

2

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	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
Average norepinephrine infusion rate	Average norepinephrine infusion rate [μg kg-1 min-1] needed to keep MAP above 65mmHg. (continuous outcome)	Perioperative
Amount of hypotensive events	Amount of hypotensive events with a MAP <65 [mmHg]	Intraoperative
Lowest MAP	Lowest MAP [mmHg]	Intraoperative
Cumulative amount of hypotensive time	Cumulative amount of hypotensive time with a MAP <65 mmHg [min]	Intraoperative
Time-weighted average MAP <65 mmHg	Time-weighted average MAP <65 mmHg (area under a MAP of 65 mmHg divided by the time from the beginning of induction of general anesthesia until the end) [mmHg]	Perioperative
Crystalloid fluid application	Amount of crystalloid fluid application [ml]	Intraoperative

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf

Study record dates

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): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Vasopressor; Stressed volume
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypotension
• 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