Fluid Responsiveness in Post-cardiac Surgery

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

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

Study Overview

• Status: Completed
• Conditions: Postoperative Complications; Cardiac Surgery; Fluid Overload
• Intervention / Treatment: Procedure: Combined end-expiratory occlusion and end-inspiratory occlusion test; Procedure: Tidal volume challenge test

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El Gharbyia
    • Tanta, El Gharbyia, Egypt, 31111
      • Faculty of medicine, Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: occlusions test; Combined end expiratory (EEO) and inspiratory occlusion (EIO) test. A 15-s EEO separated by a time window of 1 minute to allow the hemodynamic parameters to return to baseline followed by a 15-s EIO	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.
Active Comparator: challenge test; Tidal volume (TV) challenge test (transient increase of TV from 6 to 8 mL/kg for 1 minute)	Procedure: Tidal volume challenge test; elevating tidal volume from 6 ml/kg to 8 ml/kg for only 60 seconds

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2023
• Primary Completion (Actual): August 20, 2025
• Study Completion (Actual): September 1, 2025

Study Registration Dates

• First Submitted: July 14, 2023
• First Submitted That Met QC Criteria: July 21, 2023
• First Posted (Actual): July 24, 2023

Study Record Updates

• Last Update Posted (Actual): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 20, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Edema; Postoperative Complications
• Other Study ID Numbers: fluid responsiveness

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No