Pneumatic Leg Compression and Norepinephrine Requirements in Patients Having Non-cardiac Surgery
NCT ID: NCT06950606
Last Updated: 2025-06-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
238 participants
INTERVENTIONAL
2025-05-19
2025-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Pneumatic leg compression
PLC group (i.e., intervention group):
Patients assigned to the PLC group will receive a pneumatic lower limb compression sleeve during surgery.
Pneumatic leg compression
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
Routine care
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.
No interventions assigned to this group
Interventions
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Pneumatic leg compression
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 Criteria
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Inclusion Criteria
Exclusion Criteria
* 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)
45 Years
ALL
No
Sponsors
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Universitätsklinikum Hamburg-Eppendorf
OTHER
Responsible Party
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Locations
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University Medical Center Hamburg-Eppendorf
Hamburg, City state of Hamburg, Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-101383-BO-ff
Identifier Type: -
Identifier Source: org_study_id
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