Mechanical Ventilation WeaningECHODIAPH IINCT02883465
Ultrasound Diagnostic for Diaphragmatic Dysfunction in Reanimation
A study testing Diaphragmatic ultrasound in people with Mechanical Ventilation Weaning, run by Centre Hospitalier Saint Joseph Saint Luc de Lyon at 3 sites in France.
Trial summary
Extubation is a crucial step when patients are being weaned from mechanical ventilator support. Indeed, the patient has to face an increasing burden imposed to the ventilation system. The ability to overcome this event will determine the patient survival. A warning signal could be very useful is this situation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation Weaning
- What is being tested?
- Diaphragmatic ultrasound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 3 sitesFrance
- Study dates
- 6 Mar 2015to 1 Nov 2016
- 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
- Successful spontaneous breathing trial and extubation expected on the same day and 1 of the following criteria :
- Age > 65
- Mechanical ventilation during > 7 days
- Cardiac history (ischemic, rhythmic or valve cardiopathy)
- Respiratory history (documented or likely chronic respiratory failure)
Who cannot join
- Patient who is tracheotomized
- Peripheric neuromuscular disease (myasthenia, myopathy)
- Surgery circumstances that could affect the quality of the ultrasound exam (drains or bandages)
- Pregnant woman
- Age < 18
Trial locations and contacts
3 sites in 1 country.
France3 sites
Centre Hospitalier Saint Joseph Saint Luc
Lyon, 69007
Centre Hospitalier Annecy Genevois
Metz-Tessy, 74374
Centre Hospitalier Universitaire de Poitiers
Poitiers, 86021
About this study
Official title: Ultrasound Diagnostic for Diaphragmatic Dysfunction in Reanimation and Influence Over Mechanical Ventilation Weaning Period
Extubation is a crucial step when patients are being weaned from mechanical ventilator support. Indeed, the patient has to face an increasing burden imposed to the ventilation system. The ability to overcome this event will determine the patient survival. A warning signal could be very useful is this situation. 2 recent studies have shown that measuring diaphragmatic cupolas and muscular fibers thickening fraction could help to spot a population with a high risk of "diaphragmatic weakness", characterized by a high failure extubation rate. This study aims to verify that this kind of group of patients does exist.
- Conditions
- Mechanical Ventilation Weaning
- Being tested
- Diaphragmatic ultrasound
- Keywords
- diaphragmatic dysfunction, mechanical ventilation weaning, failure extubation rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragmatic ultrasoundProcedure or surgery
All patients will have a diaphragmatic ultrasound in the 4 hours before the extubation.
- a record of the right and left diaphragmatic cupolas run, with a chest approach and using a 4-5 MHz (megahertz) cardiac or abdominal sensor. 3 acquisitions for each side
- a record of the diaphragm thickening at the right and left apposition zones with a 10-12 MHz (megahertz) vascular sensor. 3 acquisitions for each side
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Other | Not described Receives: Procedure: Diaphragmatic ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extubation success rate
Extubation success rate, defined as no reintubation 7 days after the reporting extubation
Measured: 7 days after the reported extubation
Secondary outcomes (13)
Length of stay in reanimation unit (days)
Measured: At discharge of reanimation unit (up to 1 year)
Length of mechanical ventilation
Measured: At the extubation time
Number of patients with invasive or non-invasive mechanical ventilation
Resort to invasive or non-invasive mechanical ventilation
Measured: 48 hours after the extubation
Mortality
Measured: At discharge of reanimation unit (up to 1 year)
Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a clinical parameter : cough strength measured with a defined scale
The scale used to measure the cough is the following :
- absent
- inefficient
- low efficiency
- mild efficiency
- efficient
Measured: At the extubation time
Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a clinical parameter : quantity of secretions measured with a defined scale
- any secretions
- low secretions
- mild secretions
- abundant secretions
- very abundant secretions
Measured: At the extubation time
Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a clinical parameter : presence/absence or cervical tonus
Measured: At the extubation time
Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a clinical parameter : F/Vt ratio measured in breaths/min/L
Measured: At the extubation time
Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a paraclinical parameter : maximal inspiratory pressure in centimeters of water
Measured: At the extubation time
Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a paraclinical parameter : minimal expiratory pressure measured in centimeters of water
Measured: At the extubation time
Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a paraclinical parameter : peak flow measured in L/min (liters per minute)
Measured: At the extubation time
Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a paraclinical parameter : peak flow when coughing measured in L/min (liters per minute)
Measured: At the extubation time
Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a paraclinical parameter : P0,1 measured in milliseconds
Measured: At the extubation time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study start6 Mar 2015
- Primary completion28 Oct 2016
- Study completion1 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Ventilation WeaningStudies of the same condition, open and under way.
- 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
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Saint Joseph Saint Luc de Lyon
- Sponsor type
- University, hospital or other
- Collaborators
- Poitiers University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02883465
- Sponsor's protocol ID
- SJSL12014
- Acronym
- ECHODIAPH II
- Status last verified
- Apr 2024
- First submitted
- 27 May 2016
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Diagnostic for Diaphragmatic Dysfunction in Reanimation and Influence Over Mechanical Ventilation Weaning Period
- ClinicalTrials.gov ID
- NCT02883465
- Acronym / sponsor ID
- ECHODIAPH II / SJSL12014
- Conditions
- Mechanical Ventilation Weaning
- Keywords
- diaphragmatic dysfunction, mechanical ventilation weaning, failure extubation rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Centre Hospitalier Saint Joseph Saint Luc de LyonUniversity, hospital or other
- Collaborators
- Poitiers University Hospital
- Study start
- 6 Mar 2015 (actual)
- Primary completion
- 28 Oct 2016 (actual)
- Study completion
- 1 Nov 2016 (actual)
- First posted
- 30 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.
Extubation is a crucial step when patients are being weaned from mechanical ventilator support. Indeed, the patient has to face an increasing burden imposed to the ventilation system. The ability to overcome this event will determine the patient survival. A warning signal could be very useful is this situation. 2 recent studies have shown that measuring diaphragmatic cupolas and muscular fibers thickening fraction could help to spot a population with a high risk of "diaphragmatic weakness", characterized by a high failure extubation rate. This study aims to verify that this kind of group of patients does exist.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Other | Procedure: Diaphragmatic ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Successful spontaneous breathing trial and extubation expected on the same day and 1 of the following criteria :
- Age > 65
- Mechanical ventilation during > 7 days
- Cardiac history (ischemic, rhythmic or valve cardiopathy)
- Respiratory history (documented or likely chronic respiratory failure)
Key exclusion criteria (5 listed)
- Patient who is tracheotomized
- Peripheric neuromuscular disease (myasthenia, myopathy)
- Surgery circumstances that could affect the quality of the ultrasound exam (drains or bandages)
- Pregnant woman
- Age < 18
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 |
|---|---|---|
| Diaphragmatic ultrasoundAll patients will have a diaphragmatic ultrasound in the 4 hours before the extubation. * a record of the right and left diaphragmatic cupolas run, with a chest approach and using a 4-5 MHz (megahertz) cardiac or abdominal sensor. 3 acquisitions for each side * a record of the diaphragm thickening at the right and left apposition zones with a 10-12 MHz (megahertz) vascular sensor. 3 acquisitions for each side | Procedure or surgery | Single arm |
Primary outcome
Extubation success rate
Time frame: 7 days after the reported extubation
Extubation success rate, defined as no reintubation 7 days after the reporting extubation
13 secondary outcomes
Length of stay in reanimation unit (days)
Time frame: At discharge of reanimation unit (up to 1 year)
Length of mechanical ventilation
Time frame: At the extubation time
Number of patients with invasive or non-invasive mechanical ventilation
Time frame: 48 hours after the extubation
Mortality
Time frame: At discharge of reanimation unit (up to 1 year)
Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a clinical parameter : cough strength measured with a defined scale
Time frame: At the extubation time
Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a clinical parameter : quantity of secretions measured with a defined scale
Time frame: At the extubation time
Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a clinical parameter : presence/absence or cervical tonus
Time frame: At the extubation time
Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a clinical parameter : F/Vt ratio measured in breaths/min/L
Time frame: At the extubation time
Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a paraclinical parameter : maximal inspiratory pressure in centimeters of water
Time frame: At the extubation time
Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a paraclinical parameter : minimal expiratory pressure measured in centimeters of water
Time frame: At the extubation time
Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a paraclinical parameter : peak flow measured in L/min (liters per minute)
Time frame: At the extubation time
Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a paraclinical parameter : peak flow when coughing measured in L/min (liters per minute)
Time frame: At the extubation time
Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a paraclinical parameter : P0,1 measured in milliseconds
Time frame: At the extubation time
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 4 Apr 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diaphragmatic ultrasound in people with Mechanical Ventilation Weaning, run by Centre Hospitalier Saint Joseph Saint Luc 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 5 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 4 Apr 2024. 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?
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?
Extubation success rate (time frame: 7 days after the reported extubation). 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 4 Apr 2024.