CClinicalTrials.gg
CompletedNCT06423833Updated May 8, 2025

Trendelenburg Maneuver Versus Passive Leg Raising Test for Fluid Responsiveness in High-Risk Surgical Patients

An interventional study of Trendelenburg maneuver (TM) and Passive leg raising test in Trendelenburg Maneuver, Passive Leg Raising and High-Risk Surgical Patients, sponsored by Tanta University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-08.

Sponsored by Tanta University · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Feb 2023, registered May 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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

02

Conditions studied

  • Trendelenburg Maneuver
  • Passive Leg Raising
  • High-Risk Surgical Patients
03

In context

Lead sponsor

Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Aged ≥ 18 years old.
  • Criteria of high-risk surgical patients:

    1. Elderly ≥ 70 years old undergoing major surgery.
    2. Physical status ≥ 3 or more undergoing major surgery.
    3. Major intraoperative hemorrhage with Surgical Apgar Score (SAS 0-4).
    4. Emergency of upper abdominal surgery.
  • Criteria of hypoperfusion ≥ 2 or more the following:

    1. Mean arterial blood pressure \< 65 mmHg.
    2. Urine output \< 0.5 ml/Kg/hr.
    3. Capillary refilling time > 4 seconds.
    4. Blood lactate > 2 mmol/L.
    5. ScvO2 \< 70%.
    6. CO2 gap > 6 mmHg.
  • Provided that:SpO2 ≥ 90% and Hb ≥ 7 g/dl.

Exclusion criteria

Exclusion Criteria:

  • 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]).
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Trendelenburg maneuver

    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 (TM)

  • Active comparator
    Passive leg raising 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

    Diagnostic Test: Passive leg raising test

Interventions

  • Diagnostic testTrendelenburg 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 testPassive leg raising 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: At the end of Trendelenburg maneuver and passive leg raising test within 1 minute

07

Study locations

1 site
  • Tanta University Hospitals
    Tanta, El-Gharbia 31527, Egypt
08

References and documents

Individual participant data

Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06423833
Lead sponsor
Tanta University
Responsible party
Fatma Mohamed Samy Elaiashy (Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt, Tanta University) — Principal investigator
First posted
May 21, 2024
Start date
Feb 1, 2023
Primary completion
May 6, 2025
Completion
May 6, 2025
Last update
May 8, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion