Instrumental respiratory physiotherapy for patients struggling to wean off ventilators

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of an early and systematic instrumental respiratory physiotherapy approach in patients who are difficult to wean off mechanical ventilation and have developed ICU-acquired neuromyopathy. The intervention aims to improve cough strength, measured by peak expiratory flow (PEF), compared to standard respiratory physiotherapy. By enhancing cough strength, the study seeks to reduce the risk of reintubation and improve patient outcomes during the weaning process from mechanical ventilation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patient 18 years or more, affiliated to a social security system
* Patients on invasive mechanical ventilation for 48 hours or more
* Failure of at least one mechanical ventilation weaning test (spontaneous breathing trial, SBT)
* First successful SBT on the day of eligibility assessment
* Medical Research Council (MRC) score \< 48 and/or cough strength ≤ 2 on the 6-point Likert scale

Exclusion Criteria:

* Recent brain injury (\< 3 months, stroke, cardiopulmonary arrest)
* Delirium tremens (Cushman score \> 7)
* Chronic neuromuscular pathology
* Patient under continuous intravenous sedation
* Patient unresponsive to simple commands and Richmond Agitation and Sedation Scale (RASS) score \< -2 or \> +1
* FiO2: Inspired Oxygen Fraction\> 50%, percutaneous, O2: oxygen saturation \< 88%, positive end-expiratory pressure \> 5 centimeter of water (cmH2O) or respiratory rate ≥ 35 min-1
* Vasopressor catecholamine at a dose \> 0.5 μg/kg/min
* Tracheostomized patient
* Undrained pneumothorax
* Pulmonary emphysema (identified as antecedent in medical record)
* Uncontrolled hemoptysis
* Surgery \< 3 months of esophagus and/or the ear, nose and throat (ENT) sphere
* Pregnancy or lactating
* Patient deprived of liberty by judicial or administrative decision
* Patient under guardianship or curatorship
* Patient already included in the same study or in another study sharing the same primary endpoint

Where it's running

• Médecine Intensive - Réanimation, Hôpital de la Croix Rousse
  Lyon, France Recruiting
• Département d'Anesthésie Réanimation - Médecine Intensive, Centre Hospitalier Lyon Sud
  Lyon, France Recruiting
• Service d'Anesthésie et Réanimation, Hôpital de la Croix Rousse, GHN
  Lyon, France, France Not yet recruiting

Study contacts

• Study coordinator: Maria CLEYET, MSc
• Email: maria.cleyet@chu-lyon.fr
• Phone: 04 26 10 94 93

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.