Status:

RECRUITING

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

Lead Sponsor:

Universitätsklinikum Hamburg-Eppendorf

Conditions:

Hypotension During Surgery

Eligibility:

All Genders

45+ years

Phase:

NA

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 witho...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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)

Key Trial Info

Start Date :

May 19 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

October 1 2025

Estimated Enrollment :

238 Patients enrolled

Trial Details

Trial ID

NCT06950606

Start Date

May 19 2025

End Date

October 1 2025

Last Update

June 8 2025

Active Locations (1)

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University Medical Center Hamburg-Eppendorf

Hamburg, Hamburg, Germany, 20246