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New treatment option for Ventilator Weaning
Official title Instrumental Respiratory Physiotherapy in Difficult-to-wean ICU Patients
ClinicalTrials.gov ID: NCT06499389
What this study is testing
- What it's testing
- Difficult ventilatory weaning is associated with a 20% mortality rate. 40% of these patients will develop intensive care unit (ICU)-acquired neuromyopathy, associated with reduced cough strength and a 4-fold increase in the risk of reintubation.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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 \ +1
- FiO2: Inspired Oxygen Fraction\> 50%, percutaneous, O2: oxygen saturation \ 5 centimeter of water (cmH2O) or respiratory rate ≥ 35 min-1
See the full eligibility 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
- 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 \ +1
- FiO2: Inspired Oxygen Fraction\> 50%, percutaneous, O2: oxygen saturation \ 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
The study team makes the final eligibility decision.
Where it's taking place
- Lyon, France, France
- Lyon, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lyon, France, France; Lyon, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.