Instrumental Respiratory Physiotherapy in Difficult-to-wean ICU Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-18

Study Completion Date

2027-05-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Ventilator Weaning

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intensive instrumental and early respiratory physiotherapy

Patients in this arm will receive instrumental and intensive respiratory physiotherapy strategy from inclusion to day 7, 3 times a day, before and after extubation. Instrumental physiotherapy will be protocolized and cough strength and efficacy of bronchial secretions clearance will be evaluated

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

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).

Protocolized standard-of-care respiratory physiotherapy

Patients in this group will receive standardized and protocolized respiratory physiotherapy, i.e. 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.

Group Type ACTIVE_COMPARATOR

Protocolized standard-of-care respiratory physiotherapy

Intervention Type PROCEDURE

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

Interventions

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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).

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No