Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06450678
Status:
RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-06-05
Brief Title:
Use of a Physiotherapy Assessment to Predict Extubation Failure in Mechanically Ventilated Patients the EPIC Assessment
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Use of a Physiotherapy Assessment to Predict Extubation Failure in Mechanically Ventilated Patients the EPIC Assessment
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PREDEXTUB
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 patients 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
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 patients 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 cyclesmin
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 patients 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
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 cyclesmin
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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-A01734-41 | OTHER | ID-RCB | None |