Weaning From Mechanical VentilationPREDRICNCT02855619
Comparison of the Impact of Three Programs of Inspiratory Muscles.
A study testing Martin, Cader and EDRIC in people with Weaning From Mechanical Ventilation, run by University Hospital, Bordeaux at 2 sites in France.
Trial summary
Ventilator-induced diaphragmatic dysfunction appears to contribute to slow weaning from mechanical ventilation. Several trials of inspiratory muscle training to facilitate weaning in intensive care have been performed, with inconsistent results, utilizing different methods of IMT in different populations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weaning From Mechanical Ventilation
- What is being tested?
- Martin, Cader and EDRIC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 2 sitesFrance
- Study dates
- 15 Oct 2016to 22 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 ventilated more than 18h in a controlled mode;
- First single breathe trial of 2 hours failure;
- Presence of sevrability criterias definied by the European consensus conference in 2007 an usually used:
- diminution of the sedfative agents,
- Patients with spontaneous beath in VAC mode or patient ventilated in a VSAI-PEP mode,
- PaO2/FiO2 ≥150,
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- Absence d'inotropes ou de vasopresseurs à forte dose ou dose croissante (<1mg/h),
- SaO2 > 90% with FiO2 ≤ 50%,
- PEP ≤ 8cmH2O,
- Corporal température between 36°C and 39°C,
- Glasgow Score ≥ 8.
Who cannot join
- Age < 18 years ;
- medically unstable;
- Poor vital pronostic at very short term;
- Cardiac arrest with a poor neurological prognostic;
- Neuromuscular disease ;
- Pneumothorax non drained ;
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- Tracheostomy ;
- Current pregnancy ;
- Patients with guardianship or trusteeship.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Réanimation Médicale
Bordeaux, 33076
Réanimation Médicale
Lyon, 69004
About this study
Official title: Comparison of the Incidence of 3 Inspiratory Muscle Training Programs on Inspiratory Strength, on Difficult to Wean Patients in Intensive Care Unit: a Multi-centre Randomised Trial.
Ventilator-induced diaphragmatic dysfunction appears to contribute to slow weaning from mechanical ventilation. Several trials of inspiratory muscle training to facilitate weaning in intensive care have been performed, with inconsistent results, utilizing different methods of IMT in different populations.
In this study, the investigators want to compare the incidence of 3 inspiratory muscle training programs on inspiratory strength, on difficult to wean patients in intensive care unit.
Read more
This is a multi-center randomized trial not blinded with 3 parallels groups:
- Martin's group: a threshold-based IMT is performed like used by Martin in a randomized trial in 2011, in a view of inspiratory strength increase.
- Cader's group: a threshold-based IMT is performed like used by Cader in a randomized trial in 2010 , in a view of inspiratory endurance increase.
- EDRIC's group: a new treshold-based IMT is performed, in a view of both inspiratory strength and endurance increase.
The investigators think that a new threshold-based IMT performed in a view of both inspiratory strength and endurance increase, is more effective and well tolerated than the 2 others protocols.
Read the detailed description
The main objective of this study is to determinate which IMT program is the most effective on the inspiratory muscle strength and endurance increase. The investigators will be able to study the impact on the weaning time of IMT performed with the best protocol.
The investigators are going to conduct a randomized trial with intention-to-treat analysis. Following 18h of invasive mechanical ventilation in a controlled mode, the failure of the first single breathe trial of 2 hours and the presence of sevrability criterias defined by the European consensus conference in 2007, 88 participants will be included. Participants will be randomizesd to receive one of the 3 protocols of IMT, 2 times per day, 7 days per week, from the inclusion to the extubation.
The ratio of randomization will be 1:1:2 for a better evaluation of EDRIC's group wich propose a new IMT protocol.
- Conditions
- Weaning From Mechanical Ventilation
- Being tested
- Martin, Cader, EDRIC
- Keywords
- inspiratory muscles training programs, Ventilator-induced diaphragmatic dysfunction, Weaning, Intensive care unit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MartinProcedure or surgery
The physiotherapist perform the IMT using the threshold IMT inspiratory muscle trainer, connected to the intubation tube. He manage the resistance to the higher resistance tolerated by the patient in a set of 6 breaths. Participant repeats 4 sets of 6-10 breaths with 2 minutes of resting with mechanical ventilation between each set.
This treatment is made twice a day, 7days per week from inclusion to extubation exept if Glasgow score is under 8, hyperthermia more than 39°c, haemodynamic's instability, or hypoxemia( PaO2/FiO2<150).
CaderProcedure or surgery
The physiotherapist perform the IMT using the threshold IMT inspiratory muscle trainer, connected to the intubation tube. He manage the resistance to 30% of the Maximal Inspiratory Pressure initially recorded the day of the inclusion. Participant breaths against this resistance during 5 minutes. The resistance is daily increased of 10 % to the higher tolerated.
This treatment is made twice a day, 7days per week from inclusion to extubation exept if Glasgow score is under 8, hyperthermia more than 39°c, haemodynamic's instability, or hypoxemia( PaO2/FiO2<150).
EDRICProcedure or surgery
The physiotherapist perform the IMT using the threshold IMT inspiratory muscle trainer, connected to the intubation tube. He manage the resistance at 30% of the Maximal Inspiratory Pressure of the day for the first set of 20 breaths with a resistance 's increasment of 10% at each set. Participant repeats 4 sets of 20 breaths with 2 minutes of resting with mechanical ventilation between each set.
This treatment is made twice a day, 7days per week from inclusion to extubation exept if Glasgow score is under 8, hyperthermia more than 39°c, haemodynamic's instability, or hypoxemia( PaO2/FiO2<150).
| Study group | Role | What they receive |
|---|---|---|
| Martin | Active comparator | A threshold-based IMT is performed like used by Martin in a randomized trial in 2011, in a view of inspiratory strength increase. Receives: Procedure: Martin |
| Cader | Active comparator | A threshold-based IMT is performed like used by Cader in a randomized trial in 2012, in a view of inspiratory endurance increase. Receives: Procedure: Cader |
| EDRIC | Experimental | A new threshold-based IMT is performed, in a view of both inspiratory strength and endurance increase. Receives: Procedure: EDRIC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Inspiratory Pressure score (inspiratory muscle strength index) performed by an external electronic device connected with a unidirectional valve.
Measured: Baseline and up to day 25
Secondary outcomes (5)
Peak Pressure (inspiratory muscle endurance index) performed by an incremental threshold test.
Measured: Baseline and up to day 25
Duration of the weaning period
Measured: up to day 25
ICU lengh of stay
Measured: Day 30
Weaning success
Measured: up to day 27
Adverse events
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2016 (estimated)
- Study start15 Oct 2016
- Primary completion22 Feb 2020
- Study completion22 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Weaning From Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Perez, Professor, Study chair, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02855619
- Sponsor's protocol ID
- CHUBX2015/25
- Acronym
- PREDRIC
- Status last verified
- May 2020
- First submitted
- 28 Jul 2016
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Reginault T, Martinez Alejos R, Coueron R, Burle JF, Boyer A, Frison E, Vargas F. Impacts of three inspiratory muscle training programs on inspiratory muscles strength and endurance among intubated and mechanically ventilated patients with difficult weaning: a multicentre randomised controlled trial. J Intensive Care. 2024 Jul 25;12(1):28. doi: 10.1186/s40560-024-00741-3.
PubMed 39049092
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Incidence of 3 Inspiratory Muscle Training Programs on Inspiratory Strength, on Difficult to Wean Patients in Intensive Care Unit: a Multi-centre Randomised Trial.
- ClinicalTrials.gov ID
- NCT02855619
- Acronym / sponsor ID
- PREDRIC / CHUBX2015/25
- Conditions
- Weaning From Mechanical Ventilation
- Keywords
- inspiratory muscles training programs, Ventilator-induced diaphragmatic dysfunction, Weaning, Intensive care unit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 15 Oct 2016 (actual)
- Primary completion
- 22 Feb 2020 (actual)
- Study completion
- 22 Mar 2020 (actual)
- First posted
- 4 Aug 2016 (estimated)
- 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.
Ventilator-induced diaphragmatic dysfunction appears to contribute to slow weaning from mechanical ventilation. Several trials of inspiratory muscle training to facilitate weaning in intensive care have been performed, with inconsistent results, utilizing different methods of IMT in different populations.
In this study, the investigators want to compare the incidence of 3 inspiratory muscle training programs on inspiratory strength, on difficult to wean patients in intensive care unit.
This is a multi-center randomized trial not blinded with 3 parallels groups:
- Martin's group: a threshold-based IMT is performed like used by Martin in a randomized trial in 2011, in a view of inspiratory strength increase.
- Cader's group: a threshold-based IMT is performed like used by Cader in a randomized trial in 2010 , in a view of inspiratory endurance increase.
- EDRIC's group: a new treshold-based IMT is performed, in a view of both inspiratory strength and endurance increase.
The investigators think that a new threshold-based IMT performed in a view of both inspiratory strength and endurance increase, is more effective and well tolerated than the 2 others protocols.
Detailed description
The main objective of this study is to determinate which IMT program is the most effective on the inspiratory muscle strength and endurance increase. The investigators will be able to study the impact on the weaning time of IMT performed with the best protocol.
The investigators are going to conduct a randomized trial with intention-to-treat analysis. Following 18h of invasive mechanical ventilation in a controlled mode, the failure of the first single breathe trial of 2 hours and the presence of sevrability criterias defined by the European consensus conference in 2007, 88 participants will be included. Participants will be randomizesd to receive one of the 3 protocols of IMT, 2 times per day, 7 days per week, from the inclusion to the extubation.
The ratio of randomization will be 1:1:2 for a better evaluation of EDRIC's group wich propose a new IMT protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Martin | Active comparator | Procedure: MartinA threshold-based IMT is performed like used by Martin in a randomized trial in 2011, in a view of inspiratory strength increase. |
| Cader | Active comparator | Procedure: CaderA threshold-based IMT is performed like used by Cader in a randomized trial in 2012, in a view of inspiratory endurance increase. |
| EDRIC | Experimental | Procedure: EDRICA new threshold-based IMT is performed, in a view of both inspiratory strength and endurance increase. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patient ventilated more than 18h in a controlled mode;
- First single breathe trial of 2 hours failure;
- Presence of sevrability criterias definied by the European consensus conference in 2007 an usually used:
Key exclusion criteria (9 listed)
- Age < 18 years ;
- medically unstable;
- Poor vital pronostic at very short term;
- Cardiac arrest with a poor neurological prognostic;
- Neuromuscular disease ;
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 |
|---|---|---|
| MartinThe physiotherapist perform the IMT using the threshold IMT inspiratory muscle trainer, connected to the intubation tube. He manage the resistance to the higher resistance tolerated by the patient in a set of 6 breaths. Participant repeats 4 sets of 6-10 breaths with 2 minutes of resting with mechanical ventilation between each set. This treatment is made twice a day, 7days per week from inclusion to extubation exept if Glasgow score is under 8, hyperthermia more than 39°c, haemodynamic's instability, or hypoxemia( PaO2/FiO2<150). | Procedure or surgery | Martin |
| CaderThe physiotherapist perform the IMT using the threshold IMT inspiratory muscle trainer, connected to the intubation tube. He manage the resistance to 30% of the Maximal Inspiratory Pressure initially recorded the day of the inclusion. Participant breaths against this resistance during 5 minutes. The resistance is daily increased of 10 % to the higher tolerated. This treatment is made twice a day, 7days per week from inclusion to extubation exept if Glasgow score is under 8, hyperthermia more than 39°c, haemodynamic's instability, or hypoxemia( PaO2/FiO2<150). | Procedure or surgery | Cader |
| EDRICThe physiotherapist perform the IMT using the threshold IMT inspiratory muscle trainer, connected to the intubation tube. He manage the resistance at 30% of the Maximal Inspiratory Pressure of the day for the first set of 20 breaths with a resistance 's increasment of 10% at each set. Participant repeats 4 sets of 20 breaths with 2 minutes of resting with mechanical ventilation between each set. This treatment is made twice a day, 7days per week from inclusion to extubation exept if Glasgow score is under 8, hyperthermia more than 39°c, haemodynamic's instability, or hypoxemia( PaO2/FiO2<150). | Procedure or surgery | EDRIC |
Primary outcome
Maximal Inspiratory Pressure score (inspiratory muscle strength index) performed by an external electronic device connected with a unidirectional valve.
Time frame: Baseline and up to day 25
5 secondary outcomes
Peak Pressure (inspiratory muscle endurance index) performed by an incremental threshold test.
Time frame: Baseline and up to day 25
Duration of the weaning period
Time frame: up to day 25
ICU lengh of stay
Time frame: Day 30
Weaning success
Time frame: up to day 27
Adverse events
Time frame: Day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Results publication: PubMed 39049092Reginault T, Martinez Alejos R, Coueron R, Burle JF, Boyer A, Frison E, Vargas F. Impacts of three inspiratory muscle training programs on inspiratory muscles strength and endurance among intubated and mechanically ventilated patients with difficult weaning: a multicentre randomised controlled trial. J Intensive Care. 2024 Jul 25;12(1):28. doi: 10.1186/s40560-024-00741-3.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Paul Perez, Professor study chair
University Hospital, Bordeaux
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Martin, Cader and EDRIC in people with Weaning From Mechanical Ventilation, run by University Hospital, Bordeaux at 2 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 11 inclusion and 9 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: finished, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal Inspiratory Pressure score (inspiratory muscle strength index) performed by an external electronic device connected with a unidirectional valve. (time frame: Baseline and up to day 25). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02855619, which also lists 1 linked publication.
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 31 Aug 2026.