Mechanical Ventilator WeaningPREDEXTUBNCT06450678
Use of a Physiotherapy Assessment to Predict Extubation Failure in Mechanically Ventilated Patients: the EPIC Assessment
An observational study of Mechanical Ventilator Weaning and Mechanical Ventilation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilator Weaning, Mechanical Ventilation
- How many people
- 330 participants
- Where
- 1 siteFrance
- Study dates
- 15 Apr 2024to Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients admitted to intensive care and placed on invasive mechanical ventilation for more than 48 hours
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Michael THY contact
France1 site, 1 recruiting
- Recruiting
Bichat - Claude Bernard Hospital
Paris, 75018
Antoine SHENOUDA, Physiotherapist, 06 52 94 89 74 ext. 33, antoine.shenouda@aphp.fr
Michael THY, michael.thy@aphp.fr
About this study
"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.
Read more
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."
Read the 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).
- Keywords
- ICU, extubation failure, predictive factors, physiotherapist
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adult patients with mechanical ventilation | Adult patients admitted to intensive care with mechanical ventilation for more than 48 hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
extubation failure rate
Measured: day 7 after extubation
Secondary outcomes (19)
extubation failure rate
Measured: 48h after extubation
extubation failure rate
Measured: 72h after extubation
Length of stay in post-extubation intensive care unit
Measured: 1 month
Total length of hospital stay post-extubation
Measured: 1 month
in-hospital death rate
Measured: 1 month
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).
Measured: at extubation
"Favourable" or "unfavourable" rating by two assessors (physiotherapists) blind to the other assessor's rating
Measured: at extubation
Medical decision to extubate (or not) the patient following a positive (or negative) opinion from the physiotherapist
Measured: at extubation
Glasgow Coma Scale
before extubation
Measured: The intubated patient's GCS does not take into account the verbal component, as the patient is unable to speak.
Rapid Shallow Breathing Index
"RSBI is performed within the first few minutes of the assessment by the physiotherapists.
On the ventilator, the mean tidal volumes in one minute are taken, and the respiratory rate is also measured."
Measured: before extubation
Measurement of Maximum Inspiratory Pressure
MIP is obtained on the ventilator, using the dedicated function. The physiotherapist applies a 7-second expiratory pause at the end of exhalation and asks the patient to inhale. This maneuver is performed 3 times, and the best of the three values is taken into account.
Measured: before extubation
Measurement of Peak Expiratory Flow
Measured: before extubation
Measurement of Bronchial congestion
The patient's state of congestion is rated by the physiotherapist, taking into account the patient's state of congestion over the 24 hours (assessed by the nurses and orderlies during rounds and noted on the sign) and according to the aspirations performed.
Measured: before extubation
Measurement of Salivary stasis
The patient's salivary stasis status is rated by the physiotherapist, taking into account the patient's salivary stasis over the 24 hours (assessed by the nurses and orderlies during rounds and noted on the sign) and according to the aspirations performed.
Measured: before extubation
Measurement of Orofacial motor control
The patient is asked to: open the mouth; stick out the tongue and move it to the right and left; smile.
Measured: before extubation
Measurement of Cervical spine flexion
The patient is asked to lift his or her head from the pillow and to hold it there.
Measured: before extubation
Measurement of Nausea reflex
The physiotherapist inserts a 10ml syringe between the patient's teeth, and stimulates the right and left pillars of the pharynx with a finger. A contraction of the pharynx accompanied by a sensation of discomfort on the part of the patient validates the presence of the nausea reflex
Measured: before extubation
Medical Research Council
Measured: before extubation
Laryngeal lift
Measured: before extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start15 Apr 2024
- Primary completionApr 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Ventilator WeaningStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine SHENOUDA, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06450678
- Sponsor's protocol ID
- APHP231743
- Other IDs
- 2023-A01734-41
- Acronym
- PREDEXTUB
- Status last verified
- Mar 2026
- First submitted
- 5 Jun 2024
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Physiotherapy Assessment to Predict Extubation Failure in Mechanically Ventilated Patients: the EPIC Assessment
- ClinicalTrials.gov ID
- NCT06450678
- Acronym / sponsor ID
- PREDEXTUB / APHP231743
- Keywords
- ICU, extubation failure, predictive factors, physiotherapist
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 10 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"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).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients with mechanical ventilation | – | –Adult patients admitted to intensive care with mechanical ventilation for more than 48 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted to intensive care and placed on invasive mechanical ventilation for more than 48 hours
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- Tracheostomized patient
- Severe psychiatric pathology or cognitive disorders
- Uncooperative patient
- Patient under therapeutic restriction (terminal extubation)
- Patient who has already participated in research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
extubation failure rate
Time frame: day 7 after extubation
19 secondary outcomes
extubation failure rate
Time frame: 48h after extubation
extubation failure rate
Time frame: 72h after extubation
Length of stay in post-extubation intensive care unit
Time frame: 1 month
Total length of hospital stay post-extubation
Time frame: 1 month
in-hospital death rate
Time frame: 1 month
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).
Time frame: at extubation
"Favourable" or "unfavourable" rating by two assessors (physiotherapists) blind to the other assessor's rating
Time frame: at extubation
Medical decision to extubate (or not) the patient following a positive (or negative) opinion from the physiotherapist
Time frame: at extubation
Glasgow Coma Scale
Time frame: The intubated patient's GCS does not take into account the verbal component, as the patient is unable to speak.
Rapid Shallow Breathing Index
Time frame: before extubation
Measurement of Maximum Inspiratory Pressure
Time frame: before extubation
Measurement of Peak Expiratory Flow
Time frame: before extubation
Measurement of Bronchial congestion
Time frame: before extubation
Measurement of Salivary stasis
Time frame: before extubation
Measurement of Orofacial motor control
Time frame: before extubation
Measurement of Cervical spine flexion
Time frame: before extubation
Measurement of Nausea reflex
Time frame: before extubation
Medical Research Council
Time frame: before extubation
Laryngeal lift
Time frame: before extubation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael THY contact
Antoine SHENOUDA principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Ventilator Weaning and Mechanical Ventilation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antoine SHENOUDA, Physiotherapist (06 52 94 89 74 ext. 33, antoine.shenouda@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
extubation failure rate (time frame: day 7 after extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.