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.

Study Overview

• Status: Completed
• Conditions: Passive Leg Raising; High-Risk Surgical Patients; Trendelenburg Maneuver
• Intervention / Treatment: Diagnostic test: Trendelenburg maneuver (TM); Diagnostic test: 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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Tanta University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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]).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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); 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.
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At the end of Trendelenburg maneuver within 1 minute

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At the end of Trendelenburg maneuver and passive leg raising test within 1 minute

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): May 6, 2025
• Study Completion (Actual): May 6, 2025

Study Registration Dates

• First Submitted: May 16, 2024
• First Submitted That Met QC Criteria: May 16, 2024
• First Posted (Actual): May 21, 2024

Study Record Updates

• Last Update Posted (Actual): May 8, 2025
• Last Update Submitted That Met QC Criteria: May 7, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 36264MD32/2/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No