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Studies

Interventional Recruiting

NCT06499389 on ClinicalTrials.gov

Instrumental Respiratory Physiotherapy in Difficult-to-wean ICU Patients

Official title: Randomized Controlled Trial Evaluating the Impact of Intensive, Instrumental and Early Respiratory Physiotherapy on Peak Expiratory Flow in Mechanically Ventilated Patients With ICU-acquired Muscle Weakness

  • Sponsor: Hospices Civils de Lyon
  • Enrollment: 50 (Estimated)
  • Study start: 2025-03-18 (Actual)
  • Primary completion: 2027-03-01 (Estimated)
  • Study completion: 2027-05-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: None
  • PrimaryPurpose: Treatment

Brief Summary

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. The objective measure of cough strength is peak expiratory flow (PEF). Instrument-assisted coughing is a respiratory physiotherapy technique capable of significantly increasing PEF in chronic neuromuscular patients and draining bronchial secretions.

The objective of the study is to determine whether an early, systematic, instrumental, intensive respiratory physiotherapy strategy in patients with difficult ventilatory weaning and ICU-acquired neuromyopathy significantly improves PEF immediately prior to extubation, compared with a conventional, protocolized management strategy.

Conditions

  • Ventilator Weaning

Intervention / Treatment

  • Procedure: Systematic and early intensive instrumental respiratory physiotherapy for patients undergoing difficult ventilatory weaning
  • Procedure: Protocolized standard-of-care respiratory physiotherapy

Primary Outcome Measures

  • Unassisted peak expiratory cough flow (PECF) under mechanical ventilation during a voluntary coughing effort (At Hour 24)
    PECF measured on the ventilator using its built-in flowmeter (PECF on unassisted coughing under mechanical ventilation). PECF is expressed in L/min.

Countries

France

Locations and Investigators

  • Service d'Anesthésie et Réanimation, Hôpital de la Croix Rousse, GHN, Lyon, France (Not yet recruiting)
    • Adrien ENEE, MKDE
  • Médecine Intensive - Réanimation, Hôpital de la Croix Rousse, Lyon, France (Recruiting)
    • Maria CLEYET, MKDE, MSc)
  • Département d'Anesthésie Réanimation - Médecine Intensive, Centre Hospitalier Lyon Sud, Lyon, France (Recruiting)
    • Anaïs VISDOMINE, MKDE