Clinical trial NCT05265351: Ultrafast Ultrasound for the Functional Assessment of the Diaphragm
Official title: Ultrafast Ultrasound for the Functional Assessment of the Diaphragm: Agreement With Standards Mechanical and Electrophysiological Variables and Diagnosis Performance
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diaphragm Dysfunction
Keywords: Diaphragm
Ultrafast ultrasound imaging
Electrophysiology
Cervical magnetic stimulation
Electromyography
Lead sponsor: Institut de Myologie, France
Sponsor class: OTHER
First posted: 2022-03-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Significant relationship between maximal diaphragm tissue velocity and transdiaphragmatic twitch pressure
timeFrame: Through study completion, an average of 6 months
Secondary outcomes:
measure: Significant relationship between the diaphragm tissue latency and EMG latency
timeFrame: Through study completion, an average of 6 months
measure: Accurate discrimination between patients with or without diaphragm dysfunction using metrics derived from ultrafast ultrasound
timeFrame: Through study completion, an average of 6 months
measure: Accurate discrimination between patients with or without phrenic conduction abnormality using metrics derived from ultrafast ultrasound
timeFrame: Through study completion, an average of 6 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Département R3S - Hôpital Pitié-Salpêtrière
Study officials:
affiliation: Institute ofMyology
name: Damien BACHASSON, PhD
role: PRINCIPAL_INVESTIGATOR
References: