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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05957003
Enrollment
90
Registered
2023-07-24
Start date
2023-08-10
Completion date
2025-09-01
Last updated
2025-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fluid Overload, Cardiac Surgery, Postoperative Complications

Brief 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

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.

Interventions

PROCEDURECombined 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.

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

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The number of volume responder participants could be detected using each fluid responsiveness testimmediate postoperative periodThe 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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026