Bichat - Claude Bernard Hospital
Paris, 75018, France
Location status: Recruiting
NCT Number: NCT06450678
"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."
Interested in participating?
Request Info18 year and older
All sexes
Observational
Paris, 75018, France
Location status: Recruiting
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:
The criteria for a successful T-Tube test are:
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:
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: day 7 after extubation
Time frame: 48h after extubation
Time frame: 72h after extubation
Time frame: 1 month
Time frame: 1 month
Time frame: 1 month
Time frame: at extubation
Time frame: at extubation
Time frame: at extubation
Time frame: The intubated patient's GCS does not take into account the verbal component, as the patient is unable to speak.
before extubation
Time frame: before extubation
"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."
Time frame: before extubation
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.
Time frame: before extubation
Time frame: before extubation
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.
Time frame: before extubation
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.
Time frame: before extubation
The patient is asked to: open the mouth; stick out the tongue and move it to the right and left; smile.
Time frame: before extubation
The patient is asked to lift his or her head from the pillow and to hold it there.
Time frame: before extubation
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
Time frame: before extubation
Time frame: before extubation
Contact information is provided by the study sponsor or research team.
Assistance Publique - Hôpitaux de Paris
Other
Acronym: PREDEXTUB
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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