Weaning From Mechanical VentilationEFESNCT03140267
Assessment of Inspiratory Muscles Strength and Endurance Evolution on Difficult to Wean Patients in Intensive Care Unit
A study testing Difficult to wean patients 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?
- Difficult to wean patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesFrance
- Study dates
- 14 May 2017to 23 Jan 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 as 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;
- Patient or family consent.
Who cannot join
- Age < 18 years ;
- medically unstable;
- Poor vital pronostic at very short term;
- Cardiac arrest with a poor neurological prognostic;
- Neuromuscular disease ;
- Tracheostomy ;
- Current pregnancy ;
- Patients with guardianship or trusteeship.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital Haut-Lévêque
Bordeaux, 33000
Hôpital Pellegrin
Bordeaux, 33000
About this study
Official title: Assessment of the Evolution of Force and Endurance of Inspiratory Muscles in Intubated and Mechanically-ventilated ICU Patients With Difficult Weaning
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.
To perform the best IMT program, we need to know the physio-pathology of the diaphragm in difficult to wean patients.
Read more
This study proposes to discriminate the two main characteristics of the inspiratory muscles: strength and endurance.
By analyzing the evolution of strength and endurance during all the weaning period, we want to know which characteristic has the more deficiency to adapt in a second time an effective program of IMT.
Read the detailed description
The main objective of this study is to determinate which characteristic of inspiratory muscles between strength and endurance has more deficiency in difficult to wean patients. In a second time, the results of this study will help to choose the best IMT program to assess his impact on the weaning time.
We are going to conduct an interventional trial because of Peak Pressure measure, which is not measure in care practice. 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, 80 participants will be included in the medical intensive care unit of Bordeaux's hospital. We'll perform measurements of the Maximal Inspiratory Pressure and Peak Pressure from the inclusion to the extubation.
- Conditions
- Weaning From Mechanical Ventilation
- Being tested
- Difficult to wean patients
- Keywords
- Ventilated induced diaphragmatic dysfunction, Weaning, Inspiratory muscle training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Difficult to wean patientsDiagnostic test
Subjects will be following during 18 hours in an invasive mechanical ventilation in a controlled mode. After failure of first single breath trial during 2 hours and presence of sevrability criterias defined by the European consensus conference in 2007, Maximal Inspiratory Pressure and Peak Pressure will be measure.
| Study group | Role | What they receive |
|---|---|---|
| Difficult to wean patients | Experimental | Maximal Inspiratory Pressure and Peak Pressure from the inclusion day to the extubation day will be measure. Receives: Diagnostic Test: Difficult to wean patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Inspiratory Pressure score assessment
Correlation between Maximal Inspiratory Pressure score assessment (inspiratory muscle strength index) and duration of weaning period
Measured: Daily measure (from inclusion day (day 1) to extubation day (maximum day 28))
Secondary outcomes (6)
Peak Pressure assessment
Correlation between Peak Pressure assessment (inspiratory muscle endurance index) and duration of weaning period
Measured: Each 7 days (from inclusion day (day 1) to extubation day (maximum day 28))
Maximal Inspiratory Pressure score assessment after weaning success
Correlation between Maximal Inspiratory Pressure score assessment and weaning success (not re-intubated in the 48h post-extubation)
Measured: From inclusion day (day 1) to extubation success day (maximum day 28)
Peak Pressure assessment after weaning success
Correlation between Peak Pressure assessment and weaning success.
Measured: From inclusion day (day 1) to extubation success day (maximum day 28)
Maximal Inspiratory Pressure score assessment and hospitalization
Correlation between Maximal Inspiratory Pressure score assessment and intensive care unit length
Measured: From inclusion day (day 1) to come out of hospital day (maximum day 30)
Peak Pressure assessment and hospitalization
Correlation between Peak Pressure assessment and intensive care unit length
Measured: From inclusion day (day 1) to come out of hospital day (maximum day 30)
Adverses events
Adverses events occur during Maximal Inspiratory Pressure and Peak Pressure measures
Measured: Daily measures (from inclusion day (day 1) to come out of hospital day (maximum 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 May 2017
- Study start14 May 2017
- Primary completion23 Jan 2020
- Study completion23 Jan 2020
Why it stopped: target number of inclusion no reached
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Perez Paul, Dr, Study chair, USMR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03140267
- Sponsor's protocol ID
- CHUBX 2015/37
- Other IDs
- 2016-A01137-44
- Acronym
- EFES
- Status last verified
- May 2020
- First submitted
- 2 May 2017
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Evolution of Force and Endurance of Inspiratory Muscles in Intubated and Mechanically-ventilated ICU Patients With Difficult Weaning
- ClinicalTrials.gov ID
- NCT03140267
- Acronym / sponsor ID
- EFES / CHUBX 2015/37
- Conditions
- Weaning From Mechanical Ventilation
- Keywords
- Ventilated induced diaphragmatic dysfunction, Weaning, Inspiratory muscle training
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: target number of inclusion no reached
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 14 May 2017 (actual)
- Primary completion
- 23 Jan 2020 (actual)
- Study completion
- 23 Jan 2020 (actual)
- First posted
- 4 May 2017 (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.
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.
To perform the best IMT program, we need to know the physio-pathology of the diaphragm in difficult to wean patients.
This study proposes to discriminate the two main characteristics of the inspiratory muscles: strength and endurance.
By analyzing the evolution of strength and endurance during all the weaning period, we want to know which characteristic has the more deficiency to adapt in a second time an effective program of IMT.
Detailed description
The main objective of this study is to determinate which characteristic of inspiratory muscles between strength and endurance has more deficiency in difficult to wean patients. In a second time, the results of this study will help to choose the best IMT program to assess his impact on the weaning time.
We are going to conduct an interventional trial because of Peak Pressure measure, which is not measure in care practice. 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, 80 participants will be included in the medical intensive care unit of Bordeaux's hospital. We'll perform measurements of the Maximal Inspiratory Pressure and Peak Pressure from the inclusion to the extubation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Difficult to wean patients | Experimental | Diagnostic Test: Difficult to wean patientsMaximal Inspiratory Pressure and Peak Pressure from the inclusion day to the extubation day will be measure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 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 as usually used:
- Patient or family consent.
Key exclusion criteria (8 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 |
|---|---|---|
| Difficult to wean patientsSubjects will be following during 18 hours in an invasive mechanical ventilation in a controlled mode. After failure of first single breath trial during 2 hours and presence of sevrability criterias defined by the European consensus conference in 2007, Maximal Inspiratory Pressure and Peak Pressure will be measure. | Diagnostic test | Difficult to wean patients |
Primary outcome
Maximal Inspiratory Pressure score assessment
Time frame: Daily measure (from inclusion day (day 1) to extubation day (maximum day 28))
Correlation between Maximal Inspiratory Pressure score assessment (inspiratory muscle strength index) and duration of weaning period
6 secondary outcomes
Peak Pressure assessment
Time frame: Each 7 days (from inclusion day (day 1) to extubation day (maximum day 28))
Maximal Inspiratory Pressure score assessment after weaning success
Time frame: From inclusion day (day 1) to extubation success day (maximum day 28)
Peak Pressure assessment after weaning success
Time frame: From inclusion day (day 1) to extubation success day (maximum day 28)
Maximal Inspiratory Pressure score assessment and hospitalization
Time frame: From inclusion day (day 1) to come out of hospital day (maximum day 30)
Peak Pressure assessment and hospitalization
Time frame: From inclusion day (day 1) to come out of hospital day (maximum day 30)
Adverses events
Time frame: Daily measures (from inclusion day (day 1) to come out of hospital day (maximum day 30))
Results and safety
The study was stopped early (reason given: target number of inclusion no reached). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- 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.
Perez Paul, Dr study chair
USMR
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Difficult to wean patients 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 12 inclusion and 8 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: stopped early, as of the sponsor's last update on 30 Jun 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 was stopped early (reason given: target number of inclusion no reached). Results are not available in the source record.
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 assessment (time frame: Daily measure (from inclusion day (day 1) to extubation day (maximum day 28))). 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 30 Jun 2026.