Ultrafast Ultrasound for the Functional Assessment of the Diaphragm

Diaphragm Dysfunction Clinical Trial

— ECHOSTIM-EFR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05265351
• Other study ID #: ECHOSTIM-EFR
• Status: Recruiting
• Phase: N/A
• Start date: May 24, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: September 2023
• Source: Institut de Myologie, France
• Contact: Damien BACHASSON, PhD
• Phone: 01 42 16 66 43
• Email: d.bachasson[@]institut-myologie.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diaphragm Dysfunction

Intervention

Diagnostic Test:
• Transdiaphragmatic pressure measurement
Ultrafast ultrasound imaging of the diaphragm during artificially evoked responses
• EMG
Surface electromyography of the diaphragm for phrenic nerve conduction study

Locations

Country	Name	City	State
France	Département R3S - Hôpital Pitié-Salpêtrière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Myologie, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Significant relationship between maximal diaphragm tissue velocity and transdiaphragmatic twitch pressure		Through study completion, an average of 6 months
Secondary	Significant relationship between the diaphragm tissue latency and EMG latency		Through study completion, an average of 6 months
Secondary	Accurate discrimination between patients with or without diaphragm dysfunction using metrics derived from ultrafast ultrasound		Through study completion, an average of 6 months
Secondary	Accurate discrimination between patients with or without phrenic conduction abnormality using metrics derived from ultrafast ultrasound		Through study completion, an average of 6 months