Clinical trial Recruiting at 1 site Observational Ages 18 and up

VVI index to predict success of getting off a ventilator

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

Run by University of Thessaly · NCT07372664 · Data updated 2026-11-12

This will test whether the volume-velocity index (VVI), measured from diaphragm movement and breathing patterns, can predict which ventilated patients ready for a first weaning attempt will be successfully liberated.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment100 (estimated)
SponsorUniversity of Thessaly
Academic / other
Locations3 sites (Larissa and 2 other locations)
StatusRecruiting
StartedDecember 28, 2025
Main results expectedAugust 2027
Study endsSeptember 2027
Registry record updatedSeptember 2, 2026
Trial IDNCT07372664 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults mechanically ventilated for more than 48 hours who are undergoing their first spontaneous breathing trial and are judged ready to wean by their treating physician using published readiness criteria.

Probably not a fit

Patients who are pregnant, have preexisting diaphragmatic disease or injury, have a tracheostomy, or are not undergoing a first spontaneous breathing trial are excluded and would not benefit from this validation.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study enrolls adults mechanically ventilated for more than 48 hours who are judged ready for their first spontaneous breathing trial. Investigators will measure diaphragm excursion by ultrasound and record inspiratory time, tidal volume, and per-breath volume to calculate the volume-velocity index (VVI). Measurements will be taken in three common weaning settings (pressure support 5/5, pressure support 8/0, and T-piece or PSV 0/0) and patients will be followed to determine weaning success or failure. The aim is to externally validate a previously reported predictive index by comparing VVI results to actual liberation outcomes.

Why it matters

Potential benefit: If successful, the VVI could help clinicians identify patients who can be safely taken off mechanical ventilation sooner, reducing ventilation days, complications, and length of stay.

How similar studies have gone: A preliminary internal study reported high accuracy for the VVI, and other diaphragm-ultrasound indices have shown promise, but external validation remains limited.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • General University Hospital of Larissa
    Larissa, Greece
    Recruiting
  • AHEPA - University General Hospital
    Thessaloniki, Greece
    Not yet recruiting
  • General Hospital of Thessaloniki "G. Papanikolaou"
    Thessaloniki, Greece
    Not yet recruiting

Study contacts

  • Principal investigator: Apostolos - Alkiviadis Menis — General Hospital of Larissa
  • Study coordinator: Apostolos - Alkiviadis Menis, MD, PhD
  • Email: menis.ap.alk@gmail.com
  • Phone: +30 2413501280

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.