Ultrafast Ultrasound for the Functional Assessment of the Diaphragm (ECHOSTIM-EFR)

Institut de Myologie, France

Status: Enrolling

Conditions: Diaphragm Dysfunction

Treatments: Diagnostic Test: Transdiaphragmatic pressure measurement; Diagnostic Test: EMG

Study type: Interventional

Funder types: Other

Identifiers

NCT05265351

ECHOSTIM-EFR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Patients with confirmed or suspected diaphragm dysfunction

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Transdiaphragmatic pressure measurement

Diagnostic Test: EMG