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

High-Risk Surgical Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06423833
• Other study ID #: 36264MD32/2/23
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: May 1, 2025

Study information

• Verified date: May 2024
• Source: Tanta University
• Contact: Fatma M Elaiashy, Master
• Phone: 00201022514528
• Email: felaiashi[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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]).

Related Conditions & MeSH terms

• High-Risk Surgical Patients
• Passive Leg Raising

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Tanta University Hospitals	Tanta	El-Gharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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