Clinical trial NCT06450678: Use of a Physiotherapy Assessment to Predict Extubation Failure in Mechanically Ventilated Patients: the EPIC Assessment
Official title: Use of a Physiotherapy Assessment to Predict Extubation Failure in Mechanically Ventilated Patients: the EPIC Assessment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mechanical Ventilator Weaning
Mechanical Ventilation
Keywords: ICU
extubation failure
predictive factors
physiotherapist
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2024-06-10
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients admitted to intensive care and placed on invasive mechanical ventilation for more than 48 hours

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.

Detailed description: Adult patients admitted to the ICU and placed on invasive mechanical ventilation for more than 48 hours will be screened by the investigators (physiotherapists in conjunction with a doctor).

The spontaneous ventilation test will be carried out in the T-Tube, on the basis of a medical decision and within the framework of care, if the patients meet the weaning conditions:

* No sedation
* No inotropes or vasopressors
* Consistent response to simple commands
* FiO2 \< 50%
* PEEP \< 5 cmH2O

The criteria for a successful T-Tube test are:

* FR \< 35 cycles/min
* SpO2 \> 90%,
* Variation of less than 20% in FR or systolic blood pressure,
* No sweating, agitation or vigilance disorders.

Inclusion of patients by investigators after a successful spontaneous ventilation test.

Data will be collected describing the characteristics of patients on the day of their T-Tube test, and will also list the various risk factors for extubation failure already known in the literature, in order to avoid confounding bias

EPIC Assessment by physiotherapists: Within 30 minutes of a successful spontaneous ventilation test, the physiotherapists are called in by the nursing team to carry out the EPIC Assessment. This assessment takes the form of a table containing the following criteria:

* Glasgow Coma Scale (GCS): X \< 11 ≤ O
* Rapid Shallow Breathing Index (RSBI): X ≤ 75 \< O
* Maximum Inspiratory Pressure (MIP): X \< l-25l \< O
* Peak Expiratory Flow (PEF): X \< l-60l \< O
* Bronchial congestion: X = "++" and "+++"; O = "+" and "Ø"
* Salivary stasis: X = "++" and "+++"; O = "+" and "Ø".
* Orofacial motricity: X = Incomplete and O = Complete
* Cervical spine flexion: X = Impossible and O = Possible
* Nausea reflex: X = Absent and O = Present on at least one side.
* Medical Research Council (MRC): X \< 36 and O \> 36.

The patient is placed in a semi-sitting position, having been lifted into bed beforehand.

The physiotherapist first takes information about the starting conditions, then decreases the Inspiratory Pressure (IP) to 7 and the Positive Expiratory Pressure (PEP) to 0.

Each criterion is then assessed by the physiotherapist with the patient's participation. The cut-offs described in the literature are taken into account to validate each criterion: an "X" sign predicts extubation failure, an "O" sign predicts extubation success.

Inter-rater reproducibility study: the EPIC grids will be reviewed at the end of the research by a physiotherapist who has not carried out this EPIC, who will be responsible for giving a "favorable" or "unfavorable" opinion based on the results of the EPIC assessment (opinion not taken into account for the extubation decision - for reproducibility analysis only).

Binary global assessment: "favorable" or "unfavorable" opinion, issued collectively by the entire team in charge of the patient (physiotherapist, senior doctor, junior doctor (intern), state-registered nurse, nursing auxiliary).

Extubation decision: taken by the doctor after the spontaneous ventilation test and communication by the physiotherapists of their favorable or unfavorable opinion. Participation in the research will not affect patient management. A patient who has not been extubated will be reassessed according to the care plan in the following days (new spontaneous ventilation test, new EPIC assessment).

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

Primary outcomes:
measure: extubation failure rate
timeFrame: day 7 after extubation
Secondary outcomes:
measure: extubation failure rate
timeFrame: 48h after extubation
measure: extubation failure rate
timeFrame: 72h after extubation
measure: Length of stay in post-extubation intensive care unit
timeFrame: 1 month
measure: Total length of hospital stay post-extubation
timeFrame: 1 month
measure: in-hospital death rate
timeFrame: 1 month
measure: Binary global assessment: "favorable" or "unfavorable" opinion on extubation, given collectively by the caregivers in charge of the patient (physiotherapist, senior physician, junior physician (intern), state-registered nurse, nursing auxiliary).
timeFrame: at extubation
measure: "Favourable" or "unfavourable" rating by two assessors (physiotherapists) blind to the other assessor's rating
timeFrame: at extubation
measure: Medical decision to extubate (or not) the patient following a positive (or negative) opinion from the physiotherapist
timeFrame: at extubation
measure: Glasgow Coma Scale
timeFrame: The intubated patient's GCS does not take into account the verbal component, as the patient is unable to speak.
measure: Rapid Shallow Breathing Index
timeFrame: before extubation
measure: Measurement of Maximum Inspiratory Pressure
timeFrame: before extubation
measure: Measurement of Peak Expiratory Flow
timeFrame: before extubation
measure: Measurement of Bronchial congestion
timeFrame: before extubation
measure: Measurement of Salivary stasis
timeFrame: before extubation
measure: Measurement of Orofacial motor control
timeFrame: before extubation
measure: Measurement of Cervical spine flexion
timeFrame: before extubation
measure: Measurement of Nausea reflex
timeFrame: before extubation
measure: Medical Research Council
timeFrame: before extubation
measure: Laryngeal lift
timeFrame: before extubation
Other outcomes:
Locations:
city: Paris
country: France
facility: Bichat - Claude Bernard Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Antoine SHENOUDA
role: PRINCIPAL_INVESTIGATOR
References: