External Validation of VVI

NCT07372664 | Recruiting

• 1 other identifier: 23/17/16-12-25
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 3

Brief 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. 1.during pressure support ventilation with 5/5,
2. 2.during pressure support ventilation with 8/0,
3. 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.

Conditions

Weaning Mechanical Ventilation

Keywords

weaning; mechanical ventilation; ultrasound

Outcome Measures

Primary Outcomes (1)

• Weaning outcome

  Validate the predictive capability of VVI for weaning outcome

  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

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

Other Outcomes (4)

• VVI vs RSBI

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

• Predictive capability of VVI between long or short ventilation time

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

• VVI in various SBT modalities

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

Study Arms (1)

Patients undergoing weaning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critical Care patients undergoing weaning from mechanical ventilation

You may qualify if:

• 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)

You may not qualify if:

• pregnant patients
• preexisting diaphragmatic disease or injury
• tracheostomy

Sponsors & Collaborators

• University of Thessaly: lead

Study Sites (3)

General University Hospital of Larissa

Larissa, 41110, Greece

RECRUITING

AHEPA - University General Hospital

Thessaloniki, 54636, Greece

NOT YET RECRUITING

General Hospital of Thessaloniki "G. Papanikolaou"

Thessaloniki, 57010, Greece

NOT YET RECRUITING

Study Officials

• Apostolos - Alkiviadis Menis

  General university hospital of larissa

  PRINCIPAL INVESTIGATOR

• Demosthenes Makris

  University of Thessaly

  STUDY DIRECTOR

Central Study Contacts

Apostolos - Alkiviadis Menis, MD, PhD

CONTACT

+30 2413501280; menis.ap.alk@gmail.com

Demosthenes Makris

CONTACT

+30 2413501280; dimomakris@med.uth.gr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Intensive Care, Director of the Department of Intensive Care, General University Hospital of Larissa

Study Record Dates

• First Submitted: January 19, 2026
• First Posted: January 28, 2026
• Study Start: December 28, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GR (3)