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

Universitätsklinikum Hamburg-Eppendorf

Status: Enrolling

Conditions: Hypotension During Surgery

Treatments: Device: Pneumatic leg compression

Study type: Interventional

Funder types: Other

Identifiers

NCT06950606

2024-101383-BO-ff

Details and patient eligibility

About

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

Enrollment: 238 estimated patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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238 participants in 2 patient groups

Pneumatic leg compression

Experimental group

Description:

PLC group (i.e., intervention group): Patients assigned to the PLC group will receive a pneumatic lower limb compression sleeve during surgery.

Treatment:

Device: Pneumatic leg compression

Routine care

No Intervention group

Description:

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.