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

NCT ID: NCT06423833

Last Updated: 2025-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2025-05-06

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

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Trendelenburg maneuver (TM)

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

Passive leg raising test

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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]).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Fatma Mohamed Samy Elaiashy

Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tanta University Hospitals

Tanta, El-Gharbia, Egypt

Countries

Egypt

Other Identifiers

36264MD32/2/23

Identifier Type: -

Identifier Source: org_study_id