Ventilator WeaningPHYSIO WEANNCT06499389
Instrumental Respiratory Physiotherapy in Difficult-to-wean ICU Patients
A study testing Systematic and early intensive instrumental respiratory physiotherapy for patients undergoing difficult ventilatory weaning and Protocolized standard-of-care respiratory physiotherapy in people with Ventilator Weaning, run by Hospices Civils de Lyon at 3 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Weaning
- What is being tested?
- Systematic and early intensive instrumental respiratory physiotherapy for patients undergoing difficult ventilatory weaning and Protocolized standard-of-care respiratory physiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesFrance
- Study dates
- 18 Mar 2025to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Not yet recruiting
Service d'Anesthésie et Réanimation, Hôpital de la Croix Rousse, GHN
Lyon, France, 69004
Adrien ENEE, MKDE, 04 26 10 94 79 ext. +33, adrien.enee@chu-lyon.fr
- Recruiting
Médecine Intensive - Réanimation, Hôpital de la Croix Rousse
Lyon, 69004
Maria CLEYET, MKDE, MSc), 07.88.20.68.86 ext. +33, maria.cleyet@chu-lyon.fr
- Recruiting
Département d'Anesthésie Réanimation - Médecine Intensive, Centre Hospitalier Lyon Sud
Lyon, 69495
Anaïs VISDOMINE, MKDE, 04.78.86.66.19 ext. +33, anais.visdomine@chu-lyon.fr
About this study
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
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
- Being tested
- Systematic and early intensive instrumental respiratory physiotherapy for patients undergoing difficult ventilatory weaning, Protocolized standard-of-care respiratory physiotherapy
- Keywords
- critical care, mechanical ventilation, ventilatory weaning, peak cough expiratory flow, cough strength, mechanical cough, extubation, reintubation, chest physiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systematic and early intensive instrumental respiratory physiotherapy for patients undergoing difficult ventilatory weaningProcedure or surgery
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 physiotherapyProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Intensive instrumental and early respiratory physiotherapy | Experimental | 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 Receives: Procedure: Systematic and early intensive instrumental respiratory physiotherapy for patients undergoing difficult ventilatory weaning |
| Protocolized standard-of-care respiratory physiotherapy | Active comparator | 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. Receives: Procedure: Protocolized standard-of-care respiratory physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unassisted peak expiratory cough flow (PECF) under mechanical ventilation during a voluntary coughing effort
PECF measured on the ventilator using its built-in flowmeter (PECF on unassisted coughing under mechanical ventilation). PECF is expressed in L/min.
Measured: At Hour 24
Secondary outcomes (12)
Unassisted PECF after disconnection from mechanical ventilation during a voluntary coughing effort
PECF measured by a spirometer without ventilation, either in intubated patients after disconnection from the ventilator, and in extubated patients by application of a naso-buccal mask connected to the spirometer. PECF is expressed in L/min.
Measured: At Hour 24, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7
Assisted PECF under mechanical ventilation
PECF measured by the spirometer during the application of mechanical (instrumental) cough assistance by connecting the spirometer between the intubation tube and the Cough Assist E70 in the intubated patient, or between the nasobuccal mask and the Cough Assist E70 in the extubated patient. PECF is expressed in L/min.
Measured: At Hour 24, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7
Semi-quantitative measurement of cough strength
Measurements of cough strength using a 6-level Likert scale (0-5) for intubated patients.
Measured: At Hour 24, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7
Semi-quantitative measurement of cough strength
Measurements of cough strength using a 4-level Likert scale (0-3) for extubated patients.
Measured: At Hour 24, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7
Semi-quantitative measurement of bronchial secretion quantity
Measurements of bronchial secretion quantity using a 5-level Likert scale (0 to 4). The intensity of bronchial secretion quantity is graded semi-quantitatively by observing the quantity of secretions mobilized and/or present in the patient's airways.
Measured: At Hour 24, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7
Rate of hemodynamic instability episodes
Number of physiotherapy sessions with mean arterial pressure < 65 mmHg. Hemodynamic instability is defined as the appearance of mottles, a mean arterial pressure < 65 mm Hg and requiring urgent intervention.
Measured: At Hour 24 and after every respiratory physiotherapy session
Ratio of arterial oxygen partial pressure to fractional inspired oxygen (O2)
Ratios of arterial partial pressure in O2 to inspired fraction in O2 measured on the ventilator (P/F ratio). In extubated, non-ventilated patients, fraction of inspired oxygen (FiO2) will be estimated using the following formula: 〖fraction inspired oxygen (FiO)〗_2 (%)=21+O2 flow (in L/min)× 3. Partial oxygen pressure (PaO2) is measured on arterial blood gas.
Measured: At Hour 24, Day 7
Barotrauma complication rates
Rate of barotraumatic complications. Thoracic (X-ray or computed tomography (CT) scan for pneumomediastinum and pneumothorax) or clinical examination (subcutaneous emphysema).
Measured: At Hour 24, Day 7
Reintubation rate
Rate of reintubation
Measured: At Hour 24, Day 7
Number of days with invasive mechanical ventilation
Time, in days, between inclusion and successful liberation from the ventilator
Measured: Up to 60 days
Ventilator-free days (VFD)
Time alive and free from invasive mechanical ventilation. A VFD of 0 is adjudicated to patients who died over that period, even if they were liberated from mechanical ventilation.
Measured: Up to 60 days
Length of stay in intensive care unit
Elapsed time, in days, between inclusion and ICU discharge
Measured: Up to 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start18 Mar 2025
- Primary completion1 Mar 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator WeaningStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06499389
- Sponsor's protocol ID
- 69HCL23_1275
- Other IDs
- ID RCB
- Acronym
- PHYSIO WEAN
- Status last verified
- Jan 2026
- First submitted
- 3 Jul 2024
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06499389
- Acronym / sponsor ID
- PHYSIO WEAN / 69HCL23_1275
- Conditions
- Ventilator Weaning
- Keywords
- critical care, mechanical ventilation, ventilatory weaning, peak cough expiratory flow, cough strength, mechanical cough, extubation, reintubation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 18 Mar 2025 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 12 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive instrumental and early respiratory physiotherapy | Experimental | Procedure: Systematic and early intensive instrumental respiratory physiotherapy for patients undergoing difficult ventilatory weaningPatients 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 |
| Protocolized standard-of-care respiratory physiotherapy | Active comparator | Procedure: Protocolized standard-of-care respiratory physiotherapyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Systematic and early intensive instrumental respiratory physiotherapy for patients undergoing difficult ventilatory weaningPatients 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 or surgery | Intensive instrumental and early respiratory physiotherapy |
| Protocolized standard-of-care respiratory physiotherapyPatients 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 | Procedure or surgery | Protocolized standard-of-care respiratory physiotherapy |
Primary outcome
Unassisted peak expiratory cough flow (PECF) under mechanical ventilation during a voluntary coughing effort
Time frame: 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.
12 secondary outcomes
Unassisted PECF after disconnection from mechanical ventilation during a voluntary coughing effort
Time frame: At Hour 24, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7
Assisted PECF under mechanical ventilation
Time frame: At Hour 24, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7
Semi-quantitative measurement of cough strength
Time frame: At Hour 24, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7
Semi-quantitative measurement of cough strength
Time frame: At Hour 24, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7
Semi-quantitative measurement of bronchial secretion quantity
Time frame: At Hour 24, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7
Rate of hemodynamic instability episodes
Time frame: At Hour 24 and after every respiratory physiotherapy session
Ratio of arterial oxygen partial pressure to fractional inspired oxygen (O2)
Time frame: At Hour 24, Day 7
Barotrauma complication rates
Time frame: At Hour 24, Day 7
Reintubation rate
Time frame: At Hour 24, Day 7
Number of days with invasive mechanical ventilation
Time frame: Up to 60 days
Ventilator-free days (VFD)
Time frame: Up to 60 days
Length of stay in intensive care unit
Time frame: Up to 60 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Systematic and early intensive instrumental respiratory physiotherapy for patients undergoing difficult ventilatory weaning and Protocolized standard-of-care respiratory physiotherapy in people with Ventilator Weaning, run by Hospices Civils de Lyon at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria CLEYET, MSc (04 26 10 94 93 ext. +33, maria.cleyet@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unassisted peak expiratory cough flow (PECF) under mechanical ventilation during a voluntary coughing effort (time frame: At Hour 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.