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External Validation of VVI

External Validation of the Volume-Velocity Index for Weaning Prediction: a Multicenter Observational Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07372664
Acronym
E-VVI
Enrollment
100
Registered
2026-01-28
Start date
2025-12-28
Completion date
2027-09-01
Last updated
2026-09-02

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

Conditions

Weaning Mechanical Ventilation

Keywords

weaning, mechanical ventilation, ultrasound

Brief summary

Failure of liberation from mechanical ventilation increases days spent being mechanically ventilated, the length of stay and the morbidity of patients. Thus it is crucial that those patients who are ready to be liberated are accurately detected. In this study the investigators want to externally validate an index (the volume-velocity index, VVI) which in a preliminary study was found to predict with high accuracy the outcome of ventilator liberation. In this study, in patients who are deemed ready to undergo weaning by their treating physician the investigators will measure the excursion of the diaphragm, the principal respiratory muscle, the inspiratory time and the tidal volume and the volume breathed by the patient at each respiration in three phases: 1. during pressure support ventilation with 5/5, 2. during pressure support ventilation with 8/0, 3. during t-tube or pressure support ventilation with 0/0. All of these phases are ventilatory modalities widely used during weaning from mechanical ventilation. The investigators will evaluate whether VVI can predict accurately the weaning outcome.

Interventions

None listed

Sponsors

University of Thessaly
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

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

Inclusion criteria

* Mechanically ventilated patients for more than 48h * First Spontaneous breathing trial * Deemed as ready to undergo weaning by the treating physician, according to published readiness criteria (DOI: 10.1183/09031936.00010206)

Exclusion criteria

* pregnant patients * preexisting diaphragmatic disease or injury * tracheostomy

Design outcomes

Primary

MeasureTime frameDescription
Weaning outcomeFrom the start of the spontaneous breathing trial to failure or success at 48 hours after exubation.Validate the predictive capability of VVI for weaning outcome

Secondary

MeasureTime frameDescription
VVI for SBT or extubationFrom the start of the spontaneous breathing trial to failure or success at 48 hours after exubation.Comparison of the capability of VVI to predict SBT or extubation failure

Countries

Greece

Contacts

CONTACTApostolos - Alkiviadis Menis, MD, PhD
menis.ap.alk@gmail.com+30 2413501280
CONTACTDemosthenes Makris
dimomakris@med.uth.gr+30 2413501280
PRINCIPAL_INVESTIGATORApostolos - Alkiviadis Menis

General Hospital of Larissa

STUDY_DIRECTORDemosthenes Makris

University of Thessaly

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 3, 2026