Pneumatic Leg Compression and Norepinephrine Requirements in Patients Having Non-cardiac Surgery: a Pilot Monocentric Prospective Randomized Interventional Clinical Trial

Not Applicable

Not yet recruiting

• Conditions: Hypotension During Surgery

• Registration Number: NCT06950606
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-21
• Study First Submitted QC: 2025-04-21
• Last Update Submitted: 2025-04-21
• Study First Posted: 2025-04-30
• Last Update Posted: 2025-04-30
• Study Start: 2025-05
• Primary Completion: 2025-09
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 238

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Average norepinephrine infusion rate	Intraoperative	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)

Secondary Outcome Measures

Name	Time	Method
Average norepinephrine infusion rate	Perioperative	Average norepinephrine infusion rate \[μg kg-1 min-1\] needed to keep MAP above 65mmHg. (continuous outcome)
Amount of hypotensive events	Intraoperative	Amount of hypotensive events with a MAP \<65 \[mmHg\]
Lowest MAP	Intraoperative	Lowest MAP \[mmHg\]
Cumulative amount of hypotensive time	Intraoperative	Cumulative amount of hypotensive time with a MAP \<65 mmHg \[min\]
Time-weighted average MAP <65 mmHg	Perioperative	Time-weighted average MAP \<65 mmHg (area under a MAP of 65 mmHg divided by the time from the beginning of induction of general anesthesia until the end) \[mmHg\]
Crystalloid fluid application	Intraoperative	Amount of crystalloid fluid application \[ml\]

Trial Locations

Locations (1)

University Medical Center Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany