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

NCT06950606 | Recruiting

• 1 other identifier: 2024-101383-BO-ff
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypotension During Surgery

Keywords

Stressed volume; Vasopressor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Average norepinephrine infusion rate

  Perioperative

• Amount of hypotensive events

  Intraoperative

• Lowest MAP

  Intraoperative

• Cumulative amount of hypotensive time

  Intraoperative

• Time-weighted average MAP <65 mmHg

  Perioperative

Study Arms (2)

Pneumatic leg compression

EXPERIMENTAL

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

Routine care

NO INTERVENTION

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.

Interventions

Pneumatic leg compression DEVICE

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

Pneumatic leg compression

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, Hamburg, 20246, Germany

RECRUITING

Central Study Contacts

Dominik Müller

CONTACT

+49 152 2284 2660; d.mueller@uke.de

Bernd Saugel, MD

CONTACT

b.saugel@uke.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2025
• First Posted: April 30, 2025
• Study Start: May 19, 2025
• Primary Completion: September 1, 2025
• Study Completion: October 1, 2025
• Last Updated: June 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)