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Completed

NCT Number: NCT06423833

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University Hospitals

Tanta, El-Gharbia, 31527, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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.

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]).

Treatment and study plan

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 Test

Diagnostic 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.

Primary outcomes

  1. 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.

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

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

    Correlation between the accuracy of the percentage change in velocity time integral (VTI)during Trendelenburg maneuver and passive leg raising test will be measured.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 21, 2024
Registry last updated
May 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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