Trendelenburg ManeuverNCT06423833
Trendelenburg Maneuver Versus Passive Leg Raising Test for Fluid Responsiveness in High-Risk Surgical Patients
A study testing Trendelenburg maneuver (TM) and Passive leg raising test in people with Trendelenburg Maneuver and Passive Leg Raising, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate whether Trendelenburg maneuver can be used to predict fluid responsiveness in high-risk surgical patients in intensive care unit as compared to Passive Leg Raising test. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trendelenburg Maneuver, Passive Leg Raising, High-Risk Surgical Patients
- What is being tested?
- Trendelenburg maneuver (TM) and Passive leg raising test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2023to 6 May 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥ 18 years old.
- Criteria of high-risk surgical patients:
- Elderly ≥ 70 years old undergoing major surgery.
- Physical status ≥ 3 or more undergoing major surgery.
- Major intraoperative hemorrhage with Surgical Apgar Score (SAS 0-4).
- Emergency of upper abdominal surgery.
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- Criteria of hypoperfusion ≥ 2 or more the following:
- Mean arterial blood pressure < 65 mmHg.
- Urine output < 0.5 ml/Kg/hr.
- Capillary refilling time > 4 seconds.
- Blood lactate > 2 mmol/L.
- ScvO2 < 70%.
- CO2 gap > 6 mmHg.
- Provided that:SpO2 ≥ 90% and Hb ≥ 7 g/dl.
Who cannot join
- Patients with body mass index > 35 kg/m2.
- Pregnant female.
- Contraindications to the Trendelenburg position or PLR test (major head trauma, intra-abdominal hypertension and gastric retention).
- Poor echo window or unsatisfactory cardiac echogenicity (an inability to correctly align the Doppler beam to generate reliable velocity time integral measurements at the left ventricular outflow tract [LVOT]).
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to evaluate whether Trendelenburg maneuver can be used to predict fluid responsiveness in high-risk surgical patients in intensive care unit as compared to Passive Leg Raising test.
Read the detailed description
Passive Leg Raising test is a well validated dynamic method to predict fluid responsiveness with many advantages as it doesn't use fluid loading, its effect is reversible, and it doesn't rely on heart-lung interaction. However, it has many limitations as (has false negative effect in patients with intra-abdominal hypertension), also, it may not be suitable in some surgical patients.
Trendelenburg maneuver (TM) is often used to treat hemodynamic unstable patients when hypovolemia is suspected, through a mechanism similar to Passive Leg Raising test Yonis, et al reports that change in cardiac output during Trendelenburg maneuver is a reliable predictor of fluid responsiveness in patients with acute respiratory distress syndrome in prone position under protective ventilation. Another study reports that change in velocity time integral during trendelenburg maneuver predicts fluid responsiveness in cardiac surgical patients in operating rooms
- Being tested
- Trendelenburg maneuver (TM), Passive leg raising test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trendelenburg maneuver (TM)Diagnostic test
The investigator will measure changes in velocity time integral (VTI) and stroke volume (SV) during Trendelenburg maneuver (TM) in high-risk surgical patients by trans-thoracic Doppler echo cardiography.
Passive leg raising testDiagnostic test
The investigator will measure changes in velocity time integral (VTI) and stroke volume (SV) during Passive leg raising (PLR) test in high-risk surgical patients by trans-thoracic Doppler echo cardiography.
| Study group | Role | What they receive |
|---|---|---|
| Trendelenburg maneuver | Experimental | The investigator will measure changes in velocity time integral (VTI) and stroke volume (SV) during Trendelenburg maneuver (TM) in high-risk surgical patients by trans-thoracic Doppler echo cardiography Receives: Diagnostic Test: Trendelenburg maneuver (TM) |
| Passive leg raising test | Active comparator | The investigator will measure changes in velocity time integral (VTI) and stroke volume (SV) during passive leg raising (PLR) test in high-risk surgical patients by trans-thoracic Doppler echo cardiography Receives: Diagnostic Test: Passive leg raising test |
What is being measured
The primary outcome is the main question the study is designed to answer.
The validity of Trendelenburg maneuver
Measurement of the validity of Trendelenburg maneuver to predict fluid responsiveness by measuring the percentage change in velocity time integral (VTI) by Doppler echocardiography in high risk-surgical patients.
Measured: At the end of Trendelenburg maneuver within 1 minute
Secondary outcomes (1)
Correlation between the accuracy of the percentage change in velocity time integral (VTI) during Trendelenburg maneuver and passive leg raising test (PLR) test
Correlation between the accuracy of the percentage change in velocity time integral (VTI)during Trendelenburg maneuver and passive leg raising test will be measured.
Measured: At the end of Trendelenburg maneuver and passive leg raising test within 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start1 Feb 2023
- Primary completion6 May 2025
- Study completion6 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trendelenburg ManeuverStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Mohamed Samy Elaiashy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06423833
- Sponsor's protocol ID
- 36264MD32/2/23
- Status last verified
- May 2025
- First submitted
- 16 May 2024
- Last updated
- 8 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trendelenburg Maneuver Versus Passive Leg Raising Test for Fluid Responsiveness in High-Risk Surgical Patients
- ClinicalTrials.gov ID
- NCT06423833
- Acronym / sponsor ID
- 36264MD32/2/23
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 6 May 2025 (actual)
- Study completion
- 6 May 2025 (actual)
- First posted
- 21 May 2024 (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 aim of this study is to evaluate whether Trendelenburg maneuver can be used to predict fluid responsiveness in high-risk surgical patients in intensive care unit as compared to Passive Leg Raising test.
Detailed description
Passive Leg Raising test is a well validated dynamic method to predict fluid responsiveness with many advantages as it doesn't use fluid loading, its effect is reversible, and it doesn't rely on heart-lung interaction. However, it has many limitations as (has false negative effect in patients with intra-abdominal hypertension), also, it may not be suitable in some surgical patients.
Trendelenburg maneuver (TM) is often used to treat hemodynamic unstable patients when hypovolemia is suspected, through a mechanism similar to Passive Leg Raising test Yonis, et al reports that change in cardiac output during Trendelenburg maneuver is a reliable predictor of fluid responsiveness in patients with acute respiratory distress syndrome in prone position under protective ventilation. Another study reports that change in velocity time integral during trendelenburg maneuver predicts fluid responsiveness in cardiac surgical patients in operating rooms
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trendelenburg maneuver | Experimental | Diagnostic Test: Trendelenburg maneuver (TM)The investigator will measure changes in velocity time integral (VTI) and stroke volume (SV) during Trendelenburg maneuver (TM) in high-risk surgical patients by trans-thoracic Doppler echo cardiography |
| Passive leg raising test | Active comparator | Diagnostic Test: Passive leg raising testThe investigator will measure changes in velocity time integral (VTI) and stroke volume (SV) during passive leg raising (PLR) test in high-risk surgical patients by trans-thoracic Doppler echo cardiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Aged ≥ 18 years old.
- Criteria of high-risk surgical patients:
- Criteria of hypoperfusion ≥ 2 or more the following:
- Provided that:SpO2 ≥ 90% and Hb ≥ 7 g/dl.
Key exclusion criteria (4 listed)
- Patients with body mass index > 35 kg/m2.
- Pregnant female.
- Contraindications to the Trendelenburg position or PLR test (major head trauma, intra-abdominal hypertension and gastric retention).
- Poor echo window or unsatisfactory cardiac echogenicity (an inability to correctly align the Doppler beam to generate reliable velocity time integral measurements at the left ventricular outflow tract [LVOT]).
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 |
|---|---|---|
| Trendelenburg maneuver (TM)The investigator will measure changes in velocity time integral (VTI) and stroke volume (SV) during Trendelenburg maneuver (TM) in high-risk surgical patients by trans-thoracic Doppler echo cardiography. | Diagnostic test | Trendelenburg maneuver |
| Passive leg raising testThe investigator will measure changes in velocity time integral (VTI) and stroke volume (SV) during Passive leg raising (PLR) test in high-risk surgical patients by trans-thoracic Doppler echo cardiography. | Diagnostic test | Passive leg raising test |
Primary outcome
The validity of Trendelenburg maneuver
Time frame: At the end of Trendelenburg maneuver within 1 minute
Measurement of the validity of Trendelenburg maneuver to predict fluid responsiveness by measuring the percentage change in velocity time integral (VTI) by Doppler echocardiography in high risk-surgical patients.
1 secondary outcome
Correlation between the accuracy of the percentage change in velocity time integral (VTI) during Trendelenburg maneuver and passive leg raising test (PLR) test
Time frame: At the end of Trendelenburg maneuver and passive leg raising test within 1 minute
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 8 May 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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 Trendelenburg maneuver (TM) and Passive leg raising test in people with Trendelenburg Maneuver and Passive Leg Raising, run by Tanta University at 1 site in Egypt.
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 14 inclusion and 4 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 8 May 2025. 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 Egypt. 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?
The validity of Trendelenburg maneuver (time frame: At the end of Trendelenburg maneuver within 1 minute). 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 8 May 2025.