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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).
Step 1 :
Daily assessment of weaning criteria in accordance with the study protocol
Step 2 :
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard intervention | Active Comparator |
| |
| Personalized intervention - WIPO risk factors vs no risk factors | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard SBT | Other | Weaning strategy in accordance with the care practices of the department, regarding the assessment of weaning criteria, SBT and extubation modalities. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality 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 | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of extubation success after the first SBT. | 72 hours from first SBT | |
| Rate of reintubation | 72 hours from first SBT | |
| Rate of reintubation |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of tracheostomy during the ICU stay. | 28 days | |
| Incidence of non-invasive ventilation or high-flow nasal oxygenation post-extubation, both prophylactic and curative. | 72 hours after extubation. | |
Inclusion Criteria : all patients ≥ 18 y.o admitted to the ICU, under invasive mechanical ventilation for more then 24 hours and fullfilling the following weaning criteria :
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jules Audard | University Hospital, Clermont-Ferrand | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Bordeaux | Bordeaux | France | ||||
| CHU de Clermont-Ferrand |
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| ID | Term |
|---|---|
| D015610 | Serum Bactericidal Test |
| ID | Term |
|---|---|
| D008826 | Microbial Sensitivity Tests |
| D008828 | Microbiological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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Pragmatic, controlled, multicenter, stepped wedge cluster randomized trial, considering centers as clusters.
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Double blind is not possible as this study evaluate a care strategy. However, in order to limit evaluation bias, the methodologist will be blinded to the group.
| SBT with T-piece or PSV | Other | - 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. |
|
| 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 | 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. | 28 days |
| Number of days without mechanical ventilation | From day one of first SBT to day 28 |
| Length of stay in the ICU and in the hospital. | 90 days |
| Mortality of ICU stay/hospital stay. | 90 days |
| Mortality at day 28. | 28 days |
| Mortality at day 90. | 90 days |
| Incidence of use for diuretics or beta-blockers for failed weaning trials or WIPO. |
| 28 days |
| Incidence of the absence of extubation despite a successful SBT. | 28 days |
| Time and reason for reintubation in case of failed extubation. | 28 days |
| Clermont-Ferrand |
| France |
| CHU de Grenoble | Grenoble | France |
| CHU de Lille | Lille | France |
| CHU de Lyon - Hôpital Lyon Sud | Lyon | France |
| CHU de Montpellier | Montpellier | France |
| CHU de Nantes | Nantes | France |
| CHU de Saint-Etienne | Saint-Etienne | France |
| CHU de Toulouse | Toulouse | France |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D004353 | Drug Evaluation, Preclinical |
| D005069 | Evaluation Studies as Topic |