Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-27 @ 11:43 PM
Study NCT ID:
NCT05719194
Status:
RECRUITING
Last Update Posted:
2024-09-25
First Post:
2023-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of a Personalized Weaning Strategy on Weaning Success
Sponsor:
University Hospital, Clermont-Ferrand
Organization:
Study Overview
Official Title:
Effect of a Personalized Weaning Strategy on Weaning Success
Status:
RECRUITING
Status Verified Date:
2024-09
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:
P-Wean
Brief Summary:
Weaning from mechanical ventilation is a daily challenge in intensive care units, as it can take up to 50% of the total duration of ventilation. The longer the duration of ventilation is, the more there is complication related with it.
Even when the spontaneous breathing trial is succeeded, 10 to 20% of extubations are failed and requires re-intubation.
There is two different ways to assess if the patient is capable of breathing by its own : T-piece which can be considered as hard to succeed (it can delay extubation for some patients) or pressure support ventilation with no PEEP which can be too easy and lead to an extubation too early.
Studies have identified risk factors of weaning induced pulmonary oedema wich is one of the main cause of failed extubation (up to 60%).
The purpose of P-WEAN is to evaluate whether a personalized strategy for weaning from mechanical ventilation, including daily search for weaning criteria and individualization of the weaning modality (T-piece or pressure support ventilation with zero PEEP) based on the existence of WIPO risk factors (obesity, COPD, heart disease) improves weaning success compared with usual practice.
Even when the spontaneous breathing trial is succeeded, 10 to 20% of extubations are failed and requires re-intubation.
There is two different ways to assess if the patient is capable of breathing by its own : T-piece which can be considered as hard to succeed (it can delay extubation for some patients) or pressure support ventilation with no PEEP which can be too easy and lead to an extubation too early.
Studies have identified risk factors of weaning induced pulmonary oedema wich is one of the main cause of failed extubation (up to 60%).
The purpose of P-WEAN is to evaluate whether a personalized strategy for weaning from mechanical ventilation, including daily search for weaning criteria and individualization of the weaning modality (T-piece or pressure support ventilation with zero PEEP) based on the existence of WIPO risk factors (obesity, COPD, heart disease) improves weaning success compared with usual practice.
Detailed Description:
Before the study begin, all participating centers will be randomized to determine the time between the control and the interventional period. Patients included in the study will not be randomized individually but will be managed either according to the standard of care of the service or according to the personalized strategy (according to the stepped wedge group of the center).
* Control period: Patients will be subjected to a weaning strategy in accordance with the usual care practices of the service (evaluation of the criteria of weanability, the modalities of the spontaneous breathing trial and extubation)
* Interventional period: Patients will undergo a protocolized and standardized weaning strategy, including a daily assessment of weaning criteria, and a weaning trial (PSV or T-piece) whose modalities will be defined by the presence or the absence of weaning induced pulmonary oedema risk factors. These are :
* Obesity defined as BMI greater than 30 kg/m²
* Suspected or known COPD
* Heart disease whether it is structural (hypertrophic, dilated, valvular), functional (diastolic or systolic dysfunction), ischemic, or dysrhythmic.
Step 1 :
Daily assessment of weaning criteria in accordance with the study protocol
Step 2 :
* No risk factors : spontaneous breathing trial for 1 hour with pressure support ventilation (setting a pressure support level of 5 to 8 cm of water with no PEEP)
* Risk factors : spontaneous breathing trial with a T-piece for 1 hour, measuring protein and hemoglobin by blood sample before and after the trial.
Step 3 : Reconnecting the patient for at least 30 minutes and extubation if the SBT is successful. If not, the optimization of cardiac function or fluid overload will be the responsibility of the clinician.
Decisions regarding the use of non-invasive ventilation (NIV) or high-flow nasal oxygenation, will be made based on each centre\'s expertise and current clinical practice to minimize interference with the study procedure. However, knowing the recent data and the possible superiority of NIV in preventing post-extubation respiratory failure for high risk patients, investigators will be strongly encouraged to prioritize the prophylactic use of NIV (over high-flow nasal oxygenation) after tracheal extubation.
Patients will be assessed by members of the investigating center\'s research team (under the supervision of the centre\'s investigators) at least daily during hospitalization in the ICU and until day 28 post-randomization, as well as at discharge and at 90 days.
* Control period: Patients will be subjected to a weaning strategy in accordance with the usual care practices of the service (evaluation of the criteria of weanability, the modalities of the spontaneous breathing trial and extubation)
* Interventional period: Patients will undergo a protocolized and standardized weaning strategy, including a daily assessment of weaning criteria, and a weaning trial (PSV or T-piece) whose modalities will be defined by the presence or the absence of weaning induced pulmonary oedema risk factors. These are :
* Obesity defined as BMI greater than 30 kg/m²
* Suspected or known COPD
* Heart disease whether it is structural (hypertrophic, dilated, valvular), functional (diastolic or systolic dysfunction), ischemic, or dysrhythmic.
Step 1 :
Daily assessment of weaning criteria in accordance with the study protocol
Step 2 :
* No risk factors : spontaneous breathing trial for 1 hour with pressure support ventilation (setting a pressure support level of 5 to 8 cm of water with no PEEP)
* Risk factors : spontaneous breathing trial with a T-piece for 1 hour, measuring protein and hemoglobin by blood sample before and after the trial.
Step 3 : Reconnecting the patient for at least 30 minutes and extubation if the SBT is successful. If not, the optimization of cardiac function or fluid overload will be the responsibility of the clinician.
Decisions regarding the use of non-invasive ventilation (NIV) or high-flow nasal oxygenation, will be made based on each centre\'s expertise and current clinical practice to minimize interference with the study procedure. However, knowing the recent data and the possible superiority of NIV in preventing post-extubation respiratory failure for high risk patients, investigators will be strongly encouraged to prioritize the prophylactic use of NIV (over high-flow nasal oxygenation) after tracheal extubation.
Patients will be assessed by members of the investigating center\'s research team (under the supervision of the centre\'s investigators) at least daily during hospitalization in the ICU and until day 28 post-randomization, as well as at discharge and at 90 days.
Study Oversight
Has Oversight DMC:
False
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?: