Ultrafast Ultrasound for the Functional Assessment of the Diaphragm: Agreement With Standards Mechanical and Electrophysiological Variables and Diagnosis Performance
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Significant relationship between maximal diaphragm tissue velocity and transdiaphragmatic twitch pressure
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Transdiaphragmatic pressure measurement (Diagnostic Test)
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.
Intervention: EMG (Diagnostic Test)
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)