Hypotension During SurgeryPLANENCT06950606
Pneumatic Leg Compression and Norepinephrine Requirements in Patients Having Non-cardiac Surgery
A study testing Pneumatic leg compression in people with Hypotension During Surgery, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial 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 Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Hypotension During Surgery
- What is being tested?
- Pneumatic leg compression
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- 1 siteGermany
- Study dates
- 19 May 2025to 16 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consenting patients ≥45 years scheduled for elective non-cardiac surgery under general anesthesia that is expected to last ≥60 minutes
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
Germany1 site
University Medical Center Hamburg-Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, 20246
About this study
Official title: Pneumatic Leg Compression and Norepinephrine Requirements in Patients Having Non-cardiac Surgery: a Pilot Monocentric Prospective Randomized Interventional Clinical Trial
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
- Conditions
- Hypotension During Surgery
- Being tested
- Pneumatic leg compression
- Keywords
- Stressed volume, Vasopressor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Pneumatic leg compression | Experimental | PLC group (i.e., intervention group):
Patients assigned to the PLC group will receive a pneumatic lower limb compression sleeve during surgery. Receives: Device: Pneumatic leg compression |
| Routine care | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Intraoperative
Secondary outcomes (5)
Lowest intraoperative MAP [mmHg]
Lowest intraoperative MAP [mmHg]
Measured: Intraoperative
Cumulative intraoperative time with MAP <65 mmHg [min]
Cumulative intraoperative time with MAP <65 mmHg [min]
Measured: Intraoperative
Intraoperative area under a MAP of 65 mmHg
Intraoperative area under a MAP of 65 mmHg
Measured: 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)
Measured: Intraoperative
Volume of crystalloid fluid given during surgery [ml]
Volume of crystalloid fluid given during surgery [ml]
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start19 May 2025
- Primary completion16 Dec 2025
- Study completion16 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypotension During SurgeryStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06950606
- Sponsor's protocol ID
- 2024-101383-BO-ff
- Acronym
- PLANE
- Status last verified
- Aug 2026
- First submitted
- 21 Apr 2025
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pneumatic Leg Compression and Norepinephrine Requirements in Patients Having Non-cardiac Surgery: a Pilot Monocentric Prospective Randomized Interventional Clinical Trial
- ClinicalTrials.gov ID
- NCT06950606
- Acronym / sponsor ID
- PLANE / 2024-101383-BO-ff
- Conditions
- Hypotension During Surgery
- Keywords
- Stressed volume, Vasopressor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 19 May 2025 (actual)
- Primary completion
- 16 Dec 2025 (actual)
- Study completion
- 16 Dec 2025 (actual)
- First posted
- 30 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pneumatic leg compression | Experimental | Device: Pneumatic leg compressionPLC group (i.e., intervention group): Patients assigned to the PLC group will receive a pneumatic lower limb compression sleeve during surgery. |
| Routine care | No intervention | –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. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consenting patients ≥45 years scheduled for elective non-cardiac surgery under general anesthesia that is expected to last ≥60 minutes
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pneumatic leg compressionPatients 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 | Device | Pneumatic leg compression |
Primary outcome
Average norepinephrine infusion rate
Time frame: 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)
5 secondary outcomes
Lowest intraoperative MAP [mmHg]
Time frame: Intraoperative
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)
Time frame: Intraoperative
Volume of crystalloid fluid given during surgery [ml]
Time frame: Intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pneumatic leg compression in people with Hypotension During Surgery, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average norepinephrine infusion rate (time frame: Intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.