Fluid Responsiveness in Post-cardiac Surgery

Postoperative Complications Clinical Trial

Official title:

The Validity of Combined End-expiratory and End-inspiratory Occlusion Test and Tidal Volume Challenge Test for Prediction of Fluid Responsiveness in Immediate Post-cardiac Surgery Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05957003
• Other study ID #: fluid responsiveness
• Status: Recruiting
• Phase: N/A
• Start date: August 10, 2023
• Est. completion date: September 2024

Study information

• Verified date: November 2023
• Source: Tanta University
• Contact: tarek A Mostafa, MD
• Email: dr.tarek311[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

the study aims to examine the validity of combined end-expiratory and end-inspiratory occlusion test and tidal volume challenge test for prediction of fluid responsiveness in immediate post-cardiac surgery patients

Description:

multiple studies prove that dynamic variables based on heart-lung interactions accurately can predict fluid responsiveness in mechanically ventilated patients, including pulse pressure variation (PPV) and stroke volume (SV) variation.

Furthermore, passive leg raising (PLR), end-expiratory occlusion test, and tidal volume challenge test, "Mini"-fluid challenge are currently available to assess fluid responsiveness.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: September 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients on mechanical ventilation

• Patients =18 years of age

• patients undergoing cardiac surgery (coronary artery bypass graft, valve repair/ replacement, combined cardiac surgery)

• patients with normal systolic function of the left and right ventricle

• patient is mechanically ventilated with a protective lung strategy

Exclusion Criteria:

• Patients with Spontaneously breathing activity

• Patients undergoing emergent cardiac surgery.

• Patient with severe peripheral arterial occlusive disease

• Pregnant women

• Contraindication of passive leg raising test

• unstable post-operative course

• Post-operative complications such as uncontrolled bleeding, severe neurologic impairment, or accidental mechanical complications;

• presence of residual severe tricuspid or any valvular regurgitations

• low cardiac output, low ejection fractions (EF =45%)

• open chest,Pao2/Fio2 = 200

Related Conditions & MeSH terms

• Cardiac Surgery
• Fluid Overload
• Postoperative Complications

Intervention

Procedure:
• Combined end-expiratory occlusion and end-inspiratory occlusion test
The EEO test will be performed by interrupting the mechanical ventilation at end-expiration over 15 seconds using the end-expiratory hold button available on the ventilator. The EIO test will be performed by interrupting the mechanical ventilation at end-inspiration over 15 seconds using the end-inspiratory hold button available on the ventilator.
• Tidal volume challenge test
elevating tidal volume from 6 ml/kg to 8 ml/kg for only 60 seconds

Locations

Country	Name	City	State
Egypt	Faculty of medicine, Tanta university	Tanta	El Gharbyia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of volume responder participants could be detected using each fluid responsiveness test	The number of volume responder participants could be detected using each fluid responsiveness test including tidal volume challenge test and combined end-expiratory occlusion and end-inspiratory occlusion test	immediate postoperative period