Diaphragm DysfunctionECHOSTIM-EFRNCT05265351
Ultrafast Ultrasound for the Functional Assessment of the Diaphragm
A study testing Transdiaphragmatic pressure measurement and EMG in people with Diaphragm Dysfunction, run by Institut de Myologie, France at 1 site in France.
Trial summary
The aims of the current study are as follows: i) Investigate the relationships between indices derived from ultrafast ultrasound imaging and Pditw, ii) Investigate the relationships between indices derived from ultrafast ultrasound imaging and diaphragm EMG, iii) Investigate the performance of ultrafast ultrasound for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diaphragm Dysfunction
- What is being tested?
- Transdiaphragmatic pressure measurement and EMG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 24 May 2023to 13 Feb 2025
- 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
- > 18 years old
- Patients with confirmed diaphragm dysfunction or suspicion
- Written informed consent
- Able to comply with all protocol requirements
- Affiliate or beneficiary of a social security scheme
Who cannot join
- Known allergy to latex
- Known allergy to Lidocaine or similar product
- Pacemaker
- Guardianship/trusteeship
- Pregnant or nursing women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrafast Ultrasound for the Functional Assessment of the Diaphragm: Agreement With Standards Mechanical and Electrophysiological Variables and Diagnosis Performance
The aims of the current study are as follows:
- Investigate the relationships between indices derived from ultrafast ultrasound imaging and Pditw, ii) Investigate the relationships between indices derived from ultrafast ultrasound imaging and diaphragm EMG, iii) Investigate the performance of ultrafast ultrasound for the diagnosis of diaphragm dysfunction, iv) Investigate the ability of ultrafast ultrasound imaging to decipher the cause of diaphragm dysfunction i.e. contractility alteration and/or phrenic nerves conduction defect.
Read the detailed description
The Neuromuscular Physiology and Evaluation Laboratory of the Institute of Myology recently reported that artificially stimulated diaphragm contraction may be captured and quantified using ultrafast ultrasound imaging. By filming the diaphragm at very high frame rate, one may extract ultrasound indices such as diaphragm thickening fraction and diaphragm tissue velocity. The same team showed that these indices, in particular, maximal diaphragm tissue velocity were strongly reliable and related to Pditw in healthy subjects. This approach bridges the gap between non-volitional (that are commonly combined with internal pressure measurements) and non-invasive procedures. Whether the relationships between indices derived from ultrafast ultrasound and Pditw exist in patients presenting with actual or suspicion of diaphragm dysfunction remains to be specifically investigated. Similarly, the potential of this approach for the diagnosis of phrenic conduction abnormalities remains to be assessed as it may help to circumvent confounding factors associated with surface EMG.
- Conditions
- Diaphragm Dysfunction
- Being tested
- Transdiaphragmatic pressure measurement, EMG
- Keywords
- Diaphragm, Ultrafast ultrasound imaging, Electrophysiology, Cervical magnetic stimulation, Electromyography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transdiaphragmatic pressure measurementDiagnostic test
Also called Ultrafast ultrasound imaging
Ultrafast ultrasound imaging of the diaphragm during artificially evoked responses
EMGDiagnostic test
Surface electromyography of the diaphragm for phrenic nerve conduction study
| Study group | Role | What they receive |
|---|---|---|
| Patients with confirmed or suspected diaphragm dysfunction | Experimental | Diaphragm function will be assess. Surface electromyography of the diaphragm will be performed in parallel. The abdominals displacement will be recorded using strain gauge. The intra-thoracic and intra-abdominal pressure will be measured using esophageal and gastric catheter-balloon.
Ultrafast ultrasound imaging will be performed during Cervical and bi-lateral anterior magnetic stimulation, and during phrenic electrical stimulation. Receives: Diagnostic Test: Transdiaphragmatic pressure measurement; Diagnostic Test: EMG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant relationship between maximal diaphragm tissue velocity and transdiaphragmatic twitch pressure
Measured: Through study completion, an average of 6 months
Secondary outcomes (3)
Significant relationship between the diaphragm tissue latency and EMG latency
Measured: Through study completion, an average of 6 months
Accurate discrimination between patients with or without diaphragm dysfunction using metrics derived from ultrafast ultrasound
Measured: Through study completion, an average of 6 months
Accurate discrimination between patients with or without phrenic conduction abnormality using metrics derived from ultrafast ultrasound
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start24 May 2023
- Primary completion13 Feb 2025
- Study completion13 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diaphragm DysfunctionStudies 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
- Model description
- Patients with confirmed or suspected diaphragm dysfunction undergoing transdiaphragmatic pressure measurement in response to phrenic neurostimulation as part of their follow-up or diagnostic. During this examination, ultrafast ultrasound imaging will be performed in diaphragm to capture elicited responses to assess the relationship between the variables derived from the ultrasound of the diaphragm and the variables usually measured during the evaluation of the transdiaphragmatic twitch pressure.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Myologie, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Damien BACHASSON, PhD, Principal investigator, Institute ofMyology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05265351
- Sponsor's protocol ID
- ECHOSTIM-EFR
- Acronym
- ECHOSTIM-EFR
- Status last verified
- Jun 2026
- First submitted
- 1 Feb 2022
- Last updated
- 29 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 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrafast Ultrasound for the Functional Assessment of the Diaphragm: Agreement With Standards Mechanical and Electrophysiological Variables and Diagnosis Performance
- ClinicalTrials.gov ID
- NCT05265351
- Acronym / sponsor ID
- ECHOSTIM-EFR / ECHOSTIM-EFR
- Conditions
- Diaphragm Dysfunction
- Keywords
- Diaphragm, Ultrafast ultrasound imaging, Electrophysiology, Cervical magnetic stimulation, Electromyography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Institut de Myologie, FranceUniversity, hospital or other
- Study start
- 24 May 2023 (actual)
- Primary completion
- 13 Feb 2025 (actual)
- Study completion
- 13 Feb 2025 (actual)
- First posted
- 3 Mar 2022 (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.
The aims of the current study are as follows:
- Investigate the relationships between indices derived from ultrafast ultrasound imaging and Pditw, ii) Investigate the relationships between indices derived from ultrafast ultrasound imaging and diaphragm EMG, iii) Investigate the performance of ultrafast ultrasound for the diagnosis of diaphragm dysfunction, iv) Investigate the ability of ultrafast ultrasound imaging to decipher the cause of diaphragm dysfunction i.e. contractility alteration and/or phrenic nerves conduction defect.
Detailed description
The Neuromuscular Physiology and Evaluation Laboratory of the Institute of Myology recently reported that artificially stimulated diaphragm contraction may be captured and quantified using ultrafast ultrasound imaging. By filming the diaphragm at very high frame rate, one may extract ultrasound indices such as diaphragm thickening fraction and diaphragm tissue velocity. The same team showed that these indices, in particular, maximal diaphragm tissue velocity were strongly reliable and related to Pditw in healthy subjects. This approach bridges the gap between non-volitional (that are commonly combined with internal pressure measurements) and non-invasive procedures. Whether the relationships between indices derived from ultrafast ultrasound and Pditw exist in patients presenting with actual or suspicion of diaphragm dysfunction remains to be specifically investigated. Similarly, the potential of this approach for the diagnosis of phrenic conduction abnormalities remains to be assessed as it may help to circumvent confounding factors associated with surface EMG.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients with confirmed or suspected diaphragm dysfunction undergoing transdiaphragmatic pressure measurement in response to phrenic neurostimulation as part of their follow-up or diagnostic. During this examination, ultrafast ultrasound imaging will be performed in diaphragm to capture elicited responses to assess the relationship between the variables derived from the ultrasound of the diaphragm and the variables usually measured during the evaluation of the transdiaphragmatic twitch pressure.
| Arm | Type | Receives |
|---|---|---|
| Patients with confirmed or suspected diaphragm dysfunction | Experimental | Diagnostic Test: Transdiaphragmatic pressure measurement, Diagnostic Test: EMGDiaphragm function will be assess. Surface electromyography of the diaphragm will be performed in parallel. The abdominals displacement will be recorded using strain gauge. The intra-thoracic and intra-abdominal pressure will be measured using esophageal and gastric catheter-balloon. Ultrafast ultrasound imaging will be performed during Cervical and bi-lateral anterior magnetic stimulation, and during phrenic electrical stimulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- > 18 years old
- Patients with confirmed diaphragm dysfunction or suspicion
- Written informed consent
- Able to comply with all protocol requirements
- Affiliate or beneficiary of a social security scheme
Key exclusion criteria (5 listed)
- Known allergy to latex
- Known allergy to Lidocaine or similar product
- Pacemaker
- Guardianship/trusteeship
- Pregnant or nursing women
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 |
|---|---|---|
| Transdiaphragmatic pressure measurementAlso: Ultrafast ultrasound imagingUltrafast ultrasound imaging of the diaphragm during artificially evoked responses | Diagnostic test | Patients with confirmed or suspected diaphragm dysfunction |
| EMGSurface electromyography of the diaphragm for phrenic nerve conduction study | Diagnostic test | Patients with confirmed or suspected diaphragm dysfunction |
Primary outcome
Significant relationship between maximal diaphragm tissue velocity and transdiaphragmatic twitch pressure
Time frame: Through study completion, an average of 6 months
3 secondary outcomes
Significant relationship between the diaphragm tissue latency and EMG latency
Time frame: Through study completion, an average of 6 months
Accurate discrimination between patients with or without diaphragm dysfunction using metrics derived from ultrafast ultrasound
Time frame: Through study completion, an average of 6 months
Accurate discrimination between patients with or without phrenic conduction abnormality using metrics derived from ultrafast ultrasound
Time frame: Through study completion, an average of 6 months
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 29 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.
Damien BACHASSON, PhD principal investigator
Institute ofMyology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transdiaphragmatic pressure measurement and EMG in people with Diaphragm Dysfunction, run by Institut de Myologie, France at 1 site 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 29 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 1 site 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?
Significant relationship between maximal diaphragm tissue velocity and transdiaphragmatic twitch pressure (time frame: Through study completion, an average of 6 months). 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 29 Jun 2026.