Fluid Responsiveness in Post Cardiac Surgery Patients

NCT ID: NCT06583200

Last Updated: 2024-09-03

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2024-09-12

Brief Summary

The aim of the study is to compare end expiratory occlusion test to passive leg raising test for prediction of fluid responsiveness in post cardiac surgery mechanically ventilated patients.

Detailed Description

Circulatory hypervolemia and hypovolemia are both associated with worse outcomes.Intravenous fluids are similar to drugs, with serious adverse effects and changeful efficacy. Fluids should be administered only if indicated. Passive leg raising test transiently increase venous return which can be used to evaluate fluid responsiveness.There is growing evidence that the End expiratory occlusion (EEO) test reliably detects fluid responsiveness. In patients under mechanical ventilation, the inspiration increases intra-thoracic pressure and decreases venous return. The expiratory hold augments the cardiac preload which, in case of preload responsiveness, leads to a significant increase of cardiac output (CO).EEO prevents any variation in intra-thoracic pressure leading to an increase in venous return, cardiac preload and stroke volume in preload-responsive patients. There're no studies comparing EEO with passive leg raising test in cardiac surgery patients. So, this is the target of the study.

Conditions

Cardiac Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: SCREENING
• Blinding Strategy: TRIPLE

Study Groups

End Expiratory Occlusion Test

Pulse pressure variation before and after end expiratory occlusion test

Group Type: OTHER

End Expiratory Occlusion Test

Intervention Type: DIAGNOSTIC_TEST

All studied mechanically ventilated patients under post operative sedation. EEO test will be applied to predict probable responder and probable non-responder according to pulse pressure variation in accordance to previous study where the response to volume expansion was defined as an increase in pulse pressure of 5% or more

Passive Leg Raising Test

Intervention Type: DIAGNOSTIC_TEST

All studied mechanically ventilated patients under post operative sedation.Passive leg raising test will be applied to predict probable responder and probable non-responder according to the PPV in accordance to previous study where the response to volume expansion was defined as an increase in pulse pressure of at least 10%

Passive leg raising test

Pulse pressure variation before and after passive leg raising test

Group Type: OTHER

End Expiratory Occlusion Test

Intervention Type: DIAGNOSTIC_TEST

All studied mechanically ventilated patients under post operative sedation. EEO test will be applied to predict probable responder and probable non-responder according to pulse pressure variation in accordance to previous study where the response to volume expansion was defined as an increase in pulse pressure of 5% or more

Passive Leg Raising Test

Intervention Type: DIAGNOSTIC_TEST

All studied mechanically ventilated patients under post operative sedation.Passive leg raising test will be applied to predict probable responder and probable non-responder according to the PPV in accordance to previous study where the response to volume expansion was defined as an increase in pulse pressure of at least 10%

Interventions

End Expiratory Occlusion Test

All studied mechanically ventilated patients under post operative sedation. EEO test will be applied to predict probable responder and probable non-responder according to pulse pressure variation in accordance to previous study where the response to volume expansion was defined as an increase in pulse pressure of 5% or more

Intervention Type: DIAGNOSTIC_TEST

Passive Leg Raising Test

All studied mechanically ventilated patients under post operative sedation.Passive leg raising test will be applied to predict probable responder and probable non-responder according to the PPV in accordance to previous study where the response to volume expansion was defined as an increase in pulse pressure of at least 10%

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Age group: 21-60years old
• Sex: eligible both sexes
• Post cardiac surgery
• Sedated intubated mechanically ventilated patients (Controlled ventilation with no respiratory effort)

Exclusion Criteria

• Patients refusal
• Pregnancy or any medical condition that may affect the intra abdominal pressure.
• Lower limb deep venous thrombosis Open chest conditions impaired left-ventricular ejection fraction (<45%), arrhythmias, inter-ventricular shunt, severe peripheral arterial occlusive disease and the need for intra-aortic balloon counter pulsation

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marwa Khairy, Professor

Role: STUDY_DIRECTOR

Ain Shams University

Locations

Faculty of medicine Ain Shams University

Cairo, Cairo Governorate, Egypt

Countries

Egypt

Other Identifiers

FAMSU MD 220/2022

Identifier Type: -

Identifier Source: org_study_id