External Validation of VVI
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Weaning Mechanical Ventilation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Greece
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
External Validation of the Volume-Velocity Index for Weaning Prediction: a Multicenter Observational Study
Overview
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.
Primary outcome measures
- Weaning outcome [Time frame: From the start of the spontaneous breathing trial to failure or success at 48 hours after exubation.]
Secondary outcome measures (1)
- VVI for SBT or extubation [Time frame: From the start of the spontaneous breathing trial to failure or success at 48 hours after exubation.]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Greece · 3 centers
- General University Hospital of Larissa — Larissa
- AHEPA - University General Hospital — Thessaloniki
- General Hospital of Thessaloniki "G. Papanikolaou" — Thessaloniki
Identifiers
NCT: NCT07372664 · 23/17/16-12-25