Instrumental Respiratory Physiotherapy in Difficult-to-wean ICU Patients

Launched by HOSPICES CIVILS DE LYON · Jul 10, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new approach to help patients in the intensive care unit (ICU) who have difficulty being taken off mechanical ventilation, which is when a machine helps them breathe. This situation can be serious, as many patients experience weakness and a reduced ability to cough, which can lead to complications. The study will compare traditional care methods with a new technique called instrumental respiratory physiotherapy, which uses special tools to help improve patients' cough strength and clear mucus from their lungs before they are taken off the ventilator.

To participate in this trial, patients must be 18 years or older, have been on mechanical ventilation for at least 48 hours, and have had difficulty during a breathing test. They should also have certain weakness or cough strength issues. If eligible, participants will receive either the new physiotherapy approach or standard care, and the doctors will monitor how well they respond just before being taken off the ventilator. This study is currently recruiting participants and aims to find out if this new method can make a meaningful difference in recovery for these patients.

Gender

ALL

Eligibility criteria

• 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
• • Failure of 7 or more SBT at time of eligibility
• • 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