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RECRUITING
NCT06499389
NA

Instrumental Respiratory Physiotherapy in Difficult-to-wean ICU Patients

Sponsor: Hospices Civils de Lyon

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-03-18

Completion Date

2027-05-01

Last Updated

2026-01-20

Healthy Volunteers

No

Interventions

PROCEDURE

Systematic and early intensive instrumental respiratory physiotherapy for patients undergoing difficult ventilatory weaning

Patients randomized to this group will receive 3 sessions per day of intensive early respiratory physiotherapy with instrumental techniques from randomization to day 7, before and after any extubation. The strategy will be applied until day 7 of randomization, regardless of the patient's status (intubated or not).

PROCEDURE

Protocolized standard-of-care respiratory physiotherapy

Patients in this group will receive standardized and protocolized respiratory physiotherapy to reproduce the usual practices of non-expert centers,1 to 2 sessions of manual respiratory physiotherapy (not assisted by an instrumental technique) per day until the day of successful extubation, or until day 7 if necessary

Locations (3)

Service d'Anesthésie et Réanimation, Hôpital de la Croix Rousse, GHN

Lyon, France, France

Médecine Intensive - Réanimation, Hôpital de la Croix Rousse

Lyon, France

Département d'Anesthésie Réanimation - Médecine Intensive, Centre Hospitalier Lyon Sud

Lyon, France