NCT06450678 Use of a Physiotherapy Assessment to Predict Extubation Failure in Mechanically Ventilated Patients: the EPIC Assessment
| NCT ID | NCT06450678 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Mechanical Ventilator Weaning |
| Study Type | OBSERVATIONAL |
| Enrollment | 330 participants |
| Start Date | 2024-04-15 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 330 participants in total. It began in 2024-04-15 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Antoine SHENOUDA
PRINCIPAL INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT06450678 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Mechanical Ventilator Weaning. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06450678 currently recruiting?
Yes, NCT06450678 is actively recruiting participants. Contact the research team at antoine.shenouda@aphp.fr for enrollment information.
Where is the NCT06450678 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT06450678 clinical trial?
NCT06450678 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Antoine SHENOUDA at Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 330 participants.