Effect of a Personalized Weaning Strategy on Weaning Success
- Conditions
- Mechanical VentilationIntubationWeaning
- Interventions
- Other: Standard SBTOther: SBT with T-piece or PSV
- Registration Number
- NCT05719194
- Lead Sponsor
- University Hospital, Clermont-Ferrand
- 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, cardiopathy) 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 \>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. If it increase by more then 5% then it signs a weaning induced pulmonary oedema.
Step 3 : Reconnecting the patient for 1h and extubation if it was a success. 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 center'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 center'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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
Not provided
- Acute cerebral pathology requiring admission to intensive care and/or mechanical ventilation with tracheal intubation for neurological reasons (Glasgow score <13 at the time of intubation or CT scan abnormality): hemorrhagic stroke without or with vascular malformation (aneurysm, arterio-venous malformation...), ischemic stroke, head trauma, cerebral anoxo-ischemia after cardiac arrest.
- Tetraplegic or paraplegic patients with lesion level higher than D8.
- Peripheral neuromuscular pathology (underlying myopathy or myasthenia).
- ICU's Neuromyopathy.
- Tracheostomy.
- Patients with a decision of non-reintubation or terminal intubation.
- Pregnant or lactating women.
- Patients already included in this study.
- Patients under guardianship, curatorship or safeguard of justice.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Standard intervention Standard SBT - Personalized intervention - WIPO risk factors vs no risk factors SBT with T-piece or PSV -
- Primary Outcome Measures
Name Time Method Mortality at day 28, reintubation at 72 hours, ventilatory free days (VFDs) from first spontaneous breathing trial to day 28. 28 days 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
- Secondary Outcome Measures
Name Time Method Rate of extubation success after the first SBT. 72 hours from first SBT Rate of reintubation 72 hours from extubation Reintubation rate within 7 days of extubation. 7 days after extubation Time from first SBT to extubation. 28 days SBT failure rate 28 days 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.
Number of days without mechanical ventilation From day one of first SBT to day 28 Mortality of ICU stay/hospital stay. 90 days Length of stay in the ICU and in the hospital. 90 days Mortality at day 90. 90 days Mortality at day 28. 28 days
Trial Locations
- Locations (9)
CHU de Bordeaux
🇫🇷Bordeaux, France
CHU de Montpellier
🇫🇷Montpellier, France
CHU de Grenoble
🇫🇷Grenoble, France
CHU de Lille
🇫🇷Lille, France
CHU de Nantes
🇫🇷Nantes, France
CHU de Lyon - Hôpital Lyon Sud
🇫🇷Lyon, France
CHU de Saint-Etienne
🇫🇷Saint-Étienne, France
CHU de Toulouse
🇫🇷Toulouse, France
CHU de Clermont-Ferrand
🇫🇷Clermont-Ferrand, France