Effect of a Personalized Weaning Strategy on Weaning Success

Launched by UNIVERSITY HOSPITAL, CLERMONT-FERRAND · Jan 30, 2023

Keywords

ClinConnect Summary

This clinical trial, called P-WEAN, is looking at a new way to help patients safely stop using mechanical ventilation, which is a machine that helps them breathe. Weaning from this machine can be challenging, and sometimes patients need to go back on the ventilator after they’ve been taken off. The trial will test whether a personalized approach—where doctors assess each patient’s individual needs and risks—can improve the chances of successfully stopping mechanical ventilation compared to standard methods.

To participate in this trial, patients must be at least 18 years old and have been on mechanical ventilation for more than 24 hours. They should also show signs that their condition is improving and meet specific health criteria, such as stable blood pressure and good breathing patterns. Participants can expect to receive tailored support during the weaning process, which may include different methods of helping them breathe on their own. It’s important to note that certain patients, like those with severe neurological issues or specific medical conditions, will not be eligible for this study.

Gender

ALL

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.