Weaning Mechanical VentilationE-VVINCT07372664
External Validation of VVI
An observational study of Weaning Mechanical Ventilation, run by University of Thessaly at 3 sites in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weaning Mechanical Ventilation
- How many people
- 100 participants
- Where
- 3 sitesGreece
- Study dates
- 28 Dec 2025to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critical Care patients undergoing weaning from mechanical ventilation
Who may be able to join
- 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)
Who cannot join
- pregnant patients
- preexisting diaphragmatic disease or injury
- tracheostomy
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Greece3 sites, 3 recruiting
- Recruiting
General University Hospital of Larissa
Larissa, 41110
Apostolos - Alkiviadis Menis, +30 2413501280, menis.ap.alk@gmail.com
Apostolos Alkiviadis Menis
- Not yet recruiting
AHEPA - University General Hospital
Thessaloniki, 54636
Anna Gkiouliava, +30 2310 993 262, annagkio@gmail.com
Anna Gkiouliava
- Not yet recruiting
General Hospital of Thessaloniki "G. Papanikolaou"
Thessaloniki, 57010
Christos Karachristos, +30 2313307268, christosk2004@yahoo.gr
Christos Karachristos
About this study
Official title: External Validation of the Volume-Velocity Index for Weaning Prediction: a Multicenter Observational Study
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:
Read more
- during pressure support ventilation with 5/5,
- during pressure support ventilation with 8/0,
- 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.
- Conditions
- Weaning Mechanical Ventilation
- Keywords
- weaning, mechanical ventilation, ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing weaning | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weaning outcome
Validate the predictive capability of VVI for weaning outcome
Measured: 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
Measured: From the start of the spontaneous breathing trial to failure or success at 48 hours after exubation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start28 Dec 2025
- Primary completionAug 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weaning Mechanical VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DEMOSTHENES MAKRIS, University of Thessaly
- Investigators
- Apostolos - Alkiviadis Menis, Principal investigator, General Hospital of LarissaDemosthenes Makris, Study director, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07372664
- Sponsor's protocol ID
- 23/17/16-12-25
- Acronym
- E-VVI
- Status last verified
- Aug 2026
- First submitted
- 19 Jan 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Validation of the Volume-Velocity Index for Weaning Prediction: a Multicenter Observational Study
- ClinicalTrials.gov ID
- NCT07372664
- Acronym / sponsor ID
- E-VVI / 23/17/16-12-25
- Conditions
- Weaning Mechanical Ventilation
- Keywords
- weaning, mechanical ventilation, ultrasound
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 28 Dec 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- during pressure support ventilation with 5/5,
- during pressure support ventilation with 8/0,
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing weaning | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critical Care patients undergoing weaning from mechanical ventilation
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- pregnant patients
- preexisting diaphragmatic disease or injury
- tracheostomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Weaning outcome
Time frame: From 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
1 secondary outcome
VVI for SBT or extubation
Time frame: From the start of the spontaneous breathing trial to failure or success at 48 hours after exubation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Apostolos - Alkiviadis Menis principal investigator
General Hospital of Larissa
Demosthenes Makris study director
University of Thessaly
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Weaning Mechanical Ventilation, run by University of Thessaly at 3 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Apostolos - Alkiviadis Menis, MD, PhD (+30 2413501280, menis.ap.alk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weaning outcome (time frame: From the start of the spontaneous breathing trial to failure or success at 48 hours after exubation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.