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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06423833
Enrollment
60
Registered
2024-05-21
Start date
2023-02-01
Completion date
2025-05-06
Last updated
2025-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trendelenburg Maneuver, Passive Leg Raising, High-Risk Surgical Patients

Brief 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.

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

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.

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.

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

* 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 \[LVOT\]).

Design outcomes

Primary

MeasureTime frameDescription
The validity of Trendelenburg maneuverAt the end of Trendelenburg maneuver within 1 minuteMeasurement 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.

Secondary

MeasureTime frameDescription
Correlation between the accuracy of the percentage change in velocity time integral (VTI) during Trendelenburg maneuver and passive leg raising test (PLR) testAt the end of Trendelenburg maneuver and passive leg raising test within 1 minuteCorrelation between the accuracy of the percentage change in velocity time integral (VTI)during Trendelenburg maneuver and passive leg raising test will be measured.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026