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OpenTrials
Completed

NCT Number: NCT05957003

Fluid Responsiveness in Post-cardiac Surgery

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of medicine, Tanta university

Tanta, El Gharbyia, 31111, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Combined end-expiratory occlusion and end-inspiratory occlusion test

Procedure

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

Procedure

elevating tidal volume from 6 ml/kg to 8 ml/kg for only 60 seconds

Primary outcomes

  1. The number of volume responder participants could be detected using each fluid responsiveness test

    Time frame: immediate postoperative period

    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

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 24, 2023
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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