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Cardiovascular Abnormalities, Cardiovascular Diseases
Alexandria, Alexandria Governorate, Egypt
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Recruiting
NCT Number: NCT07372664
External Validation of VVI
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
General University Hospital of Larissa, Larissa, Greece
Loading trial locations.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
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
Secondary outcomes
-
VVI for SBT or extubation
Time frame: From 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
Other outcomes
-
VVI vs RSBI
Time frame: From the start of the spontaneous breathing trial to failure or success at 48 hours after exubation.
Comparison of the predictive capability of VVI with RSBI for weaning outcome
-
Predictive capability of VVI between long or short ventilation time
Time frame: From the start of the spontaneous breathing trial to failure or success at 48 hours after exubation.
Comparison of the redictive capability of VVI between patients ventilated for more than 7 days with patients ventilated for less than 7 days
-
VVI in various SBT modalities
Time frame: From the start of the spontaneous breathing trial to failure or success at 48 hours after exubation.
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
-
Relationship of VVI with MIP and MRC
Time frame: From the start of the spontaneous breathing trial to failure or success at 48 hours after exubation.
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.
Study contacts
Contact information is provided by the study sponsor or research team.
Apostolos - Alkiviadis Menis, MD, PhD
CONTACT
Demosthenes Makris
CONTACT
Sponsors and collaborators
Lead sponsor
University of Thessaly
Other
Registry information
Official study title
External Validation of the Volume-Velocity Index for Weaning Prediction: a Multicenter Observational Study
Acronym: E-VVI
Important dates
- Study start
- 2025
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Jan 28, 2026
- Registry last updated
- Feb 11, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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