Ultrafast Ultrasound for the Functional Assessment of the Diaphragm

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-24

Study Completion Date

2024-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Diaphragm Dysfunction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients with confirmed or suspected diaphragm dysfunction

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.

Group Type EXPERIMENTAL

Transdiaphragmatic pressure measurement

Intervention Type DIAGNOSTIC_TEST

Ultrafast ultrasound imaging of the diaphragm during artificially evoked responses

EMG

Intervention Type DIAGNOSTIC_TEST

Surface electromyography of the diaphragm for phrenic nerve conduction study

Interventions

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Transdiaphragmatic pressure measurement

Ultrafast ultrasound imaging of the diaphragm during artificially evoked responses

Intervention Type DIAGNOSTIC_TEST

EMG

Surface electromyography of the diaphragm for phrenic nerve conduction study

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Ultrafast ultrasound imaging

Eligibility Criteria

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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