Personalized weaning strategy for patients on mechanical ventilation

Effect of a Personalized Weaning Strategy on Weaning Success

This study tests if a personalized approach to help patients on mechanical ventilation breathe on their own can work better than standard care in intensive care units.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 750 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital, Clermont-Ferrand (other)
• Locations: 9 sites (Bordeaux and 8 other locations)
• Trial ID: NCT05719194 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of a personalized weaning strategy for patients undergoing mechanical ventilation in intensive care units. It compares standard care practices with a protocolized approach that includes daily assessments of weaning criteria and tailored weaning trials based on individual risk factors for weaning-induced pulmonary edema. Patients will either follow the usual care or the personalized strategy, which utilizes either pressure support ventilation or T-piece based on their specific health conditions. The goal is to improve weaning success rates and reduce the need for re-intubation.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have been on invasive mechanical ventilation for more than 24 hours and meet specific weaning criteria.

Not a fit: Patients who are not stable enough for weaning or have planned surgeries within 72 hours may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance the weaning process from mechanical ventilation, leading to better patient outcomes and reduced complications.

How similar studies have performed: Other studies have explored various weaning strategies, but this personalized approach is relatively novel and aims to address specific risk factors associated with failed extubation.

Eligibility criteria

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 :

* Resolution or improvement of the condition that led to intubation, as judged by the clinician in charge of the patient.
* Hemodynamic stability, defined as systolic blood pressure between 90 and 160 mmHg, heart rate less than 140 beats/min, without or with low doses of vasopressors.
* Glasgow score of 13 or greater and Richmond Agitation-Sedation Scale (RASS) score between -1 and +1.
* Respiratory stability defined as: oxygen saturation \> 90% with inspired oxygen fraction ≤ 0.5 and PEEP ≤ 8 cmH2O, respiratory rate \< 35/min, spontaneous tidal volume \> 5 mL/kg, and peak inspiratory pressure ≤ 15 cmH2O.
* Few secretions (\< 3 aspirations in the past 8 hours).
* Effective cough.
* Negative leak test (\>100 mL or \>10%).
* No surgery planned within 72 hours.
* Patients with a social security plan.

Exclusion Criteria:

* 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.

Where this trial is running

Bordeaux and 8 other locations

• CHU de Bordeaux — Bordeaux, France (RECRUITING)
• CHU de Clermont-Ferrand — Clermont-Ferrand, France (RECRUITING)
• CHU de Grenoble — Grenoble, France (RECRUITING)
• CHU de Lille — Lille, France (RECRUITING)
• CHU de Lyon - Hôpital Lyon Sud — Lyon, France (RECRUITING)
• CHU de Montpellier — Montpellier, France (RECRUITING)
• CHU de Nantes — Nantes, France (RECRUITING)
• CHU de Saint-Etienne — Saint-Étienne, France (RECRUITING)
• CHU de Toulouse — Toulouse, France (RECRUITING)

Study contacts

• Study coordinator: Lise Laclautre

Conditions: Weaning, Mechanical Ventilation, Intubation, WIPO, Extubation, Spontaneous Breathing Trial, T-piece, Pressure Support Ventilation