Pneumatic leg compression to reduce norepinephrine needs during non-cardiac surgery
Pneumatic Leg Compression and Norepinephrine Requirements in Patients Having Non-cardiac Surgery: a Pilot Monocentric Prospective Randomized Interventional Clinical Trial
NA · Universitätsklinikum Hamburg-Eppendorf · NCT06950606
This trial will test whether using pneumatic leg compression during general anesthesia helps people aged 45 and older having elective non-cardiac surgery need less norepinephrine to keep their mean arterial pressure above 65 mmHg.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 238 (estimated) |
| Ages | 45 Years and up |
| Sex | All |
| Sponsor | Universitätsklinikum Hamburg-Eppendorf (other) |
| Locations | 1 site (Hamburg, Free and Hanseatic City of Hamburg) |
| Trial ID | NCT06950606 on ClinicalTrials.gov |
What this trial studies
The PLANE trial is a randomized, single-center comparison of pneumatic leg compression versus routine care in adults undergoing elective non-cardiac surgery under general anesthesia. Patients aged 45 or older with operations expected to last at least 60 minutes are randomized to receive pneumatic calf compression or no compression. The primary outcome is the total amount of norepinephrine required intraoperatively to maintain a mean arterial pressure above 65 mmHg. Key exclusions include sepsis, advanced heart failure, pregnancy, ASA V/VI, thrombotic or infectious contraindications to compression, or surgical positions that prevent safe device use.
Who should consider this trial
Good fit: Ideal candidates are consenting adults aged 45 or older scheduled for elective non-cardiac surgery under general anesthesia expected to last at least 60 minutes who have no contraindication to pneumatic leg compression.
Not a fit: Patients with sepsis, severe heart failure (NYHA III/IV), ASA V/VI, pregnancy, existing thrombosis or other contraindications to leg compression, or surgeries that prevent proper compression are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could lower intraoperative vasopressor use and reduce risks and side effects associated with higher norepinephrine doses.
How similar studies have performed: Leg compression and other preload-augmenting maneuvers have reduced hypotension or vasopressor needs in some smaller or different surgical settings, but using pneumatic calf compression for this specific non-cardiac general-anesthesia population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Hamburg, Free and Hanseatic City of Hamburg
- University Medical Center Hamburg-Eppendorf — Hamburg, Free and Hanseatic City of Hamburg, Germany (RECRUITING)
Study contacts
- Study coordinator: Dominik Müller
- Email: d.mueller@uke.de
- Phone: +49 152 2284 2660
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hypotension During Surgery, Stressed volume, Vasopressor