Ultrafast Ultrasound for the Functional Assessment of the Diaphragm

Not Applicable

Recruiting

• Conditions: Diaphragm Dysfunction
• Interventions: Diagnostic Test: Transdiaphragmatic pressure measurement; Diagnostic Test: EMG

• Registration Number: NCT05265351
• Lead Sponsor: Institut de Myologie, France

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 Timeline

• Study First Submitted: 2022-02-01
• Study First Submitted QC: 2022-02-22
• Study First Posted: 2022-03-03
• Study Start: 2023-05-24
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-26
• Last Update Posted: 2023-09-28
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with confirmed or suspected diaphragm dysfunction	Transdiaphragmatic pressure measurement	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.
Patients with confirmed or suspected diaphragm dysfunction	EMG	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.

Primary Outcome Measures

Name	Time	Method
Significant relationship between maximal diaphragm tissue velocity and transdiaphragmatic twitch pressure	Through study completion, an average of 6 months

Secondary Outcome Measures

Name	Time	Method
Accurate discrimination between patients with or without diaphragm dysfunction using metrics derived from ultrafast ultrasound	Through study completion, an average of 6 months
Accurate discrimination between patients with or without phrenic conduction abnormality 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

Trial Locations

Locations (1)

Département R3S - Hôpital Pitié-Salpêtrière; 🇫🇷 Paris, France