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RecruitingNCT07372664E-VVIUpdated Sep 2, 2026

External Validation of VVI

An observational study in Weaning Mechanical Ventilation, sponsored by University of Thessaly. Recruiting at 3 sites in Greece. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-02.

Sponsored by University of Thessaly · Observational

From the registry’s dates

  • Started Dec 2025; still recruiting 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Weaning Mechanical Ventilation

Keywords

  • weaning
  • mechanical ventilation
  • ultrasound
03

In context

Lead sponsor

University of Thessaly is the lead sponsor of 195 studies on the registry; 44 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Critical Care patients undergoing weaning from mechanical ventilation

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • pregnant patients
  • preexisting diaphragmatic disease or injury
  • tracheostomy
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients undergoing weaning
06

What researchers measure

Primary outcomes

  1. Weaning outcome

    Validate the predictive capability of VVI for weaning outcome

    Time frame: From the start of the spontaneous breathing trial to failure or success at 48 hours after exubation.

Secondary outcomes

  1. VVI for SBT or extubation

    Comparison of the capability of VVI to predict SBT or extubation failure

    Time frame: From the start of the spontaneous breathing trial to failure or success at 48 hours after exubation.

Other outcomes

  1. VVI vs RSBI

    Comparison of the predictive capability of VVI with RSBI for weaning outcome

    Time frame: From the start of the spontaneous breathing trial to failure or success at 48 hours after exubation.

  2. Predictive capability of VVI between long or short ventilation time

    Comparison of the redictive capability of VVI between patients ventilated for more than 7 days with patients ventilated for less than 7 days

    Time frame: From the start of the spontaneous breathing trial to failure or success at 48 hours after exubation.

  3. VVI in various SBT modalities

    Compare the ability of VVI to predict the weaning outcome in various SBT modalities, namely Pressure Support 8/0 and Pressure Support 5/5 versus t-tube or Pressure Support 0/0

    Time frame: From the start of the spontaneous breathing trial to failure or success at 48 hours after exubation.

  4. Relationship of VVI with MIP and MRC

    evaluate the relationship of VVI with indices of strength status such as the maximal inspiratory pressure, for the respiratory muscles, and the medical research council score, for the ICU acquired weakness.

    Time frame: From the start of the spontaneous breathing trial to failure or success at 48 hours after exubation.

07

Study locations

1 of 3 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07372664
Responsible party
DEMOSTHENES MAKRIS (Professor of Intensive Care, Director of the Department of Intensive Care, General University Hospital of Larissa, University of Thessaly) — Principal investigator
First posted
Jan 28, 2026
Start date
Dec 28, 2025
Primary completion
Aug 2027 (estimated)
Completion
Sep 2027 (estimated)
Last update
Sep 2, 2026

Study contacts

Apostolos - Alkiviadis Menis, MD, PhD
Contact
menis.ap.alk@gmail.com
+30 2413501280
Demosthenes Makris
Contact
dimomakris@med.uth.gr
+30 2413501280
Apostolos - Alkiviadis Menis
principal investigator · General Hospital of Larissa
Demosthenes Makris
study director · University of Thessaly

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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