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

NCT06423833 | Completed

• 1 other identifier: 36264MD32/2/23
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

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.

  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

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

Study Arms (2)

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

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

Diagnostic Test: Passive leg raising test

Interventions

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.

Trendelenburg maneuver

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.

Passive leg raising test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 \[LVOT\]).

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Hospitals

Tanta, El-Gharbia, 31527, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: May 21, 2024
• Study Start: February 1, 2023
• Primary Completion: May 6, 2025
• Study Completion: May 6, 2025
• Last Updated: May 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author

Locations

EG (1)