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

NCT06450678 | Recruiting

• 2 other identifiers: APHP2317432023-A01734-41
• Study Type: observational
• Target: 330
• Locations: 1 country
• Sites: 1

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."

Conditions

Mechanical Ventilator Weaning; Mechanical Ventilation

Keywords

ICU; extubation failure; predictive factors; physiotherapist

Outcome Measures

Primary Outcomes (1)

• extubation failure rate

  day 7 after extubation

Secondary Outcomes (19)

• extubation failure rate

  48h after extubation

• extubation failure rate

  72h after extubation

• Length of stay in post-extubation intensive care unit

  1 month

• Total length of hospital stay post-extubation

  1 month

• in-hospital death rate

  1 month

Study Arms (1)

Adult patients with mechanical ventilation

Adult patients admitted to intensive care with mechanical ventilation for more than 48 hours

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

Adult patients admitted to intensive care and placed on invasive mechanical ventilation for more than 48 hours

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Bichat - Claude Bernard Hospital

Paris, 75018, France

RECRUITING

Study Officials

• Antoine SHENOUDA

  Assistance Publique Hopitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antoine SHENOUDA, Physiotherapist

CONTACT

06 52 94 89 74; antoine.shenouda@aphp.fr

Michael THY

CONTACT

michael.thy@aphp.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 10, 2024
• Study Start: April 15, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

FR (1)