Use of a Physiotherapy Assessment to Predict Extubation Failure in Mechanically Ventilated Patients: the EPIC Assessment

NCT06450678 · tracked via the Priya Life Science France tracker

Sponsor

Assistance Publique - Hôpitaux de Paris

Phase

Observational

Started

2024-04-15

Last updated

2026-03-27

Condition(s) studied

Mechanical Ventilator WeaningMechanical Ventilation

Study summary

"Weaning from mechanical ventilation is a crucial step in the intensive care unit. Several factors complicate weaning and increase the risk of failure. To predict the success of extubation, the spontaneous ventilation test (T-Tube) remains essential. Despite this, the failure rate is around 10-20%.

Failed extubation is not without consequences, since it increases the risk of pneumopathy and mortality. It therefore seems essential to identify potential extubation failures using effective predictive criteria. Several of these predictive criteria have been studied separately in the literature, but are still not widely used in practice. Many studies have sought to identify these predictive criteria, without actually linking them. However, when combined in a single assessment prior to extubation, they could represent a reliable prediction and decision-making aid.

In the intensive care unit at Hôpital Bichat Claude Bernard, a team of physiotherapists dedicated solely to this unit carries out a routine EPIC Assessment, combining several criteria, some of which have individually demonstrated their reliability in predicting extubation outcome. Physiotherapists are health professionals working as part of the intensive care team, and are well versed in issues relating to bronchial congestion, respiratory function and muscle strength, whether for breathing or locomotion. Similarly, their involvement in issues relating to swallowing disorders acquired in intensive care gives them an overall view of the patient's ability to protect his or her airway post-extubation. The EPIC Assessment has been designed by them to address these issues. With the help of this assessment, and by following the cut-offs of the various criteria, they link the different criteria making up the EPIC Assessment and communicate a ""favorable"" or ""unfavorable"" opinion for extubation.

Our hypothesis is that the EPIC Assessment is, in addition to its interpretation by physiotherapists, a reliable tool for predicting the outcome of extubation."

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Patient 18 years of age or older * Admitted to intensive care and placed on invasive mechanical ventilation for more than 48 hours * Having passed a T-Tube spontaneous ventilation test \< 24h Exclusion Criteria: * Tracheostomized patient * Severe psychiatric pathology or cognitive disorders * Uncooperative patient * Patient under therapeutic restriction (terminal extubation) * Patient who has already participated in research * Patient or close relative (if patient not able) opposed to research * No relative if patient unable to receive information

Primary outcome measure(s)

extubation failure rate — day 7 after extubation

Trial sites (1)

Facility	City	Region	Status
Bichat - Claude Bernard Hospital	Paris	France	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06450678 on ClinicalTrials.gov ↗ ← All trials in France