## Protocol Section
### Identification Module
**NCT ID:** NCT06423833

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

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

#### Organization Study ID Info
**ID:** 36264MD32/2/23
#### Organization
**Class:** OTHER
**Full Name:** Tanta University
### Status Module
#### Completion Date
**Date:** 2025-05-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-05-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-02-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Tanta University

#### Responsible Party

**Investigator Affiliation:** Tanta University

**Investigator Full Name:** Fatma Mohamed Samy Elaiashy

**Investigator Title:** Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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 Module

**Conditions:**

- Trendelenburg Maneuver

- Passive Leg Raising

- High-Risk Surgical Patients

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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 Names:**

- Diagnostic Test: Trendelenburg maneuver (TM)

**Label:** Trendelenburg maneuver

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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 Names:**

- Diagnostic Test: Passive leg raising test

**Label:** Passive leg raising test

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Trendelenburg maneuver

**Description:** 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.

**Name:** Trendelenburg maneuver (TM)

**Type:** DIAGNOSTIC_TEST

#### Intervention 2

**Arm Group Labels:**

- Passive leg raising test

**Description:** 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.

**Name:** Passive leg raising test

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** The validity of Trendelenburg maneuver

**Time Frame:** At the end of Trendelenburg maneuver within 1 minute

#### Secondary Outcomes

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

**Measure:** 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

### Eligibility Module

**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 Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** felaiashi@gmail.com

**Name:** Fatma M Elaiashy, Master

**Phone:** 00201022514528

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Tanta

**Contacts:**

***Contact 1:***

- **Email:** felaiashi@gmail.com

- **Name:** Fatma M Elaiashy, Master

- **Phone:** 00201022514528

- **Role:** CONTACT

***Contact 2:***

- **Name:** Salah E Elsherif, MD

- **Role:** SUB_INVESTIGATOR

***Contact 3:***

- **Name:** Hala M El-Gendy, MD

- **Role:** SUB_INVESTIGATOR

***Contact 4:***

- **Name:** Sameh M Sadek, MD

- **Role:** SUB_INVESTIGATOR

***Contact 5:***

- **Name:** Taysser M Abdalraheem, MD

- **Role:** SUB_INVESTIGATOR

**Country:** Egypt

**Facility:** Tanta University Hospitals

**State:** El-Gharbia

**Status:** RECRUITING

**Zip:** 31527

### IPD Sharing Statement Module

**Access Criteria:** The data will be available upon a reasonable request from the corresponding author

**Description:** The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

**Info Types:**

- STUDY_PROTOCOL

**IPD Sharing:** YES

**Time Frame:** After the end of study for one year.

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
