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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
750
Weaning strategy in accordance with the care practices of the department, regarding the assessment of weaning criteria, SBT and extubation modalities.
\- Risk factors of WIPO Step 1 : Daily assessment of weaning criteria in accordance with the study protocol. Step 2 : Spontaneous breathing trial with T-piece for an hour. Measure of protein and haemoglobin by blood sample before and after the trial. Step 3 : Reconnect the patient to the ventilator for at least 30 minutes and then extubate if SBT is successful. If SBT failed : no extubation and new SBT the next day. Optimization of cardiac function or fluid overload will be in charge of the investigator. \- No risk factors of WIPO Step 1 : Daily assessment of weaning criteria in accordance with the study protocol. Step 2 : Spontaneous breathing trial with pressure support ventilation (pressure support from 5 to 8 cmH20 - PEEP at 0 cmH20) for an hour. Step 3 : Reconnect the patient to the ventilator for at least 30 minutes and then extubate if SBT is successful.
CHU de Bordeaux
Bordeaux, France
RECRUITINGCHU de Clermont-Ferrand
Clermont-Ferrand, France
RECRUITINGCHU de Grenoble
Grenoble, France
RECRUITINGCHU de Lille
Lille, France
RECRUITINGCHU de Lyon - Hôpital Lyon Sud
Lyon, France
RECRUITINGCHU de Montpellier
Montpellier, France
RECRUITINGCHU de Nantes
Nantes, France
RECRUITINGCHU de Saint-Etienne
Saint-Etienne, France
RECRUITINGCHU de Toulouse
Toulouse, France
RECRUITINGMortality at day 28, reintubation at 72 hours, ventilatory free days (VFDs) from first spontaneous breathing trial to day 28.
Composite score including those three criteria such that mortality is a more severe outcome than reintubation and the number of VFDs, and reintubation is a more severe outcome than the number of VFDs
Time frame: 28 days
Rate of extubation success after the first SBT.
Time frame: 72 hours from first SBT
Rate of reintubation
Time frame: 72 hours from first SBT
Rate of reintubation
Time frame: 72 hours from extubation
Reintubation rate within 7 days of extubation.
Time frame: 7 days after extubation
Time from first SBT to extubation.
Time frame: 28 days
SBT failure rate
Defined by respiratory rate increase of 50% or \> 35/min, dyspnea, SpO2 \< 88% or decrease of 5%, heart rate increase \> 20%, systolic blood pressure increase \> 20%, agitation, sweating.
Time frame: 28 days
Number of days without mechanical ventilation
Time frame: From day one of first SBT to day 28
Length of stay in the ICU and in the hospital.
Time frame: 90 days
Mortality of ICU stay/hospital stay.
Time frame: 90 days
Mortality at day 28.
Time frame: 28 days
Mortality at day 90.
Time frame: 90 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.