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Ultrafast Ultrasound for the Functional Assessment of the Diaphragm

Ultrafast Ultrasound for the Functional Assessment of the Diaphragm: Agreement With Standards Mechanical and Electrophysiological Variables and Diagnosis Performance

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05265351
Acronym
ECHOSTIM-EFR
Enrollment
50
Registered
2022-03-03
Start date
2023-05-24
Completion date
2025-02-13
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diaphragm Dysfunction

Keywords

Diaphragm, Ultrafast ultrasound imaging, Electrophysiology, Cervical magnetic stimulation, Electromyography

Brief 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 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.

Interventions

DIAGNOSTIC_TESTTransdiaphragmatic pressure measurement

Ultrafast ultrasound imaging of the diaphragm during artificially evoked responses

DIAGNOSTIC_TESTEMG

Surface electromyography of the diaphragm for phrenic nerve conduction study

Sponsors

Institut de Myologie, France
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* \> 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

Exclusion criteria

* Known allergy to latex * Known allergy to Lidocaine or similar product * Pacemaker * Guardianship/trusteeship * Pregnant or nursing women

Design outcomes

Primary

MeasureTime frame
Significant relationship between maximal diaphragm tissue velocity and transdiaphragmatic twitch pressureThrough study completion, an average of 6 months

Secondary

MeasureTime frame
Significant relationship between the diaphragm tissue latency and EMG latencyThrough study completion, an average of 6 months
Accurate discrimination between patients with or without diaphragm dysfunction using metrics derived from ultrafast ultrasoundThrough study completion, an average of 6 months
Accurate discrimination between patients with or without phrenic conduction abnormality using metrics derived from ultrafast ultrasoundThrough study completion, an average of 6 months

Countries

France

Contacts

PRINCIPAL_INVESTIGATORDamien BACHASSON, PhD

Institute ofMyology

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 30, 2026