Ultrafast Ultrasound for the Functional Assessment of the Diaphragm (ECHOSTIM-EFR)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Diaphragm Dysfunction
• Intervention / Treatment: Diagnostic test: Transdiaphragmatic pressure measurement; Diagnostic test: EMG

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Damien BACHASSON, PhD; Phone Number: 01 42 16 66 43; Email: d.bachasson@institut-myologie.org
• Study Contact Backup: Name: Christian STRAUS, Pr; Phone Number: 01 42 17 85 74; Email: christian.straus@aphp.fr

Study Locations

• France
  • Paris, France, 75013
    • Recruiting
    • Département R3S - Hôpital Pitié-Salpêtrière
    • Sub-Investigator: Claudia LLONTOP, MD
    • Contact: Christian Strauss, MD PhD; Phone Number: 0142178578; Email: christian.straus@aphp.fr
    • Contact: Thomas Similowski, MD PhD; Phone Number: 0142167797; Email: thomas.similowski@aphp.fr
    • Sub-Investigator: Christian Straus, MD PhD
    • Sub-Investigator: Thomas SIMILOWSKI, MD PhD
    • Sub-Investigator: Martin DRES, MD PhD
    • Principal Investigator: Damien Bachasson, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Diagnostic test: Transdiaphragmatic pressure measurement; Ultrafast ultrasound imaging of the diaphragm during artificially evoked responses; Other Names: Ultrafast ultrasound imaging; Diagnostic test: EMG; Surface electromyography of the diaphragm for phrenic nerve conduction study

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Institut de Myologie, France
• Investigators: Principal Investigator: Damien BACHASSON, PhD, Institute ofMyology

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2023
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: February 1, 2022
• First Submitted That Met QC Criteria: February 22, 2022
• First Posted (Actual): March 3, 2022

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Electromyography; Diaphragm; Electrophysiology; Ultrafast ultrasound imaging; Cervical magnetic stimulation
• Other Study ID Numbers: ECHOSTIM-EFR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No