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Clinical Trials/NCT05265351
NCT05265351
Recruiting
Not Applicable

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

Institut de Myologie, France1 site in 1 country50 target enrollmentMay 24, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diaphragm Dysfunction
Sponsor
Institut de Myologie, France
Enrollment
50
Locations
1
Primary Endpoint
Significant relationship between maximal diaphragm tissue velocity and transdiaphragmatic twitch pressure
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 24, 2023
End Date
September 30, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Institut de Myologie, France
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Significant relationship between maximal diaphragm tissue velocity and transdiaphragmatic twitch pressure

Time Frame: Through study completion, an average of 6 months

Secondary Outcomes

  • Accurate discrimination between patients with or without phrenic conduction abnormality using metrics derived from ultrafast ultrasound(Through study completion, an average of 6 months)
  • Accurate discrimination between patients with or without diaphragm dysfunction using metrics derived from ultrafast ultrasound(Through study completion, an average of 6 months)
  • Significant relationship between the diaphragm tissue latency and EMG latency(Through study completion, an average of 6 months)

Study Sites (1)

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