Pneumatic Leg Compression and Norepinephrine Requirements in Patients Having Non-cardiac Surgery
Pneumatic Leg Compression and Norepinephrine Requirements in Patients Having Non-cardiac Surgery: a Pilot Monocentric Prospective Randomized Interventional Clinical Trial
Universitätsklinikum Hamburg-Eppendorf
238 participants
May 19, 2025
INTERVENTIONAL
Conditions
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
Eligibility
Inclusion Criteria1
- Consenting patients ≥45 years scheduled for elective non-cardiac surgery under general anesthesia that is expected to last ≥60 minutes
Exclusion Criteria8
- 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)
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Interventions
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
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06950606