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

Universitätsklinikum Hamburg-Eppendorf238 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

238

Conditions

Hypotension During Surgery

Interventions

Pneumatic leg compressionDEVICE

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

Eligibility

Sex: ALLMin age: 45 Years

Medical Language ↔ Plain English

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: * high risk surgery according to the 2022 ESC guideline "Guidelines on cardiovascular assessment and management of patients undergoing non-cardiac surgery" * 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)

Locations (1)

University Medical Center Hamburg-Eppendorf

Hamburg, Free and Hanseatic City of Hamburg, Germany

Outcomes

Primary Outcomes

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)

Time frame: Intraoperative

Secondary Outcomes

Lowest intraoperative MAP [mmHg]

Lowest intraoperative MAP \[mmHg\]

Time frame: Intraoperative

Cumulative intraoperative time with MAP <65 mmHg [min]

Cumulative intraoperative time with MAP \<65 mmHg \[min\]

Time frame: Intraoperative

Intraoperative area under a MAP of 65 mmHg

Time frame: Intraoperative

Intraoperative time-weighted average MAP <65 mmHg (area under a MAP of 65 mmHg divided by the monitoring time)

Intraoperative time-weighted average MAP \<65 mmHg (area under a MAP of 65 mmHg divided by the monitoring time)

Time frame: Intraoperative

Volume of crystalloid fluid given during surgery [ml]

Volume of crystalloid fluid given during surgery \[ml\]

Time frame: Intraoperative

Data from ClinicalTrials.gov

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