Ultrafast Ultrasound for the Functional Assessment of the Diaphragm

NCT05265351 | Unknown

• 1 other identifier: ECHOSTIM-EFR
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Diaphragm Dysfunction

Keywords

Diaphragm; Ultrafast ultrasound imaging; Electrophysiology; Cervical magnetic stimulation; Electromyography

Outcome Measures

Primary Outcomes (1)

• Significant relationship between maximal diaphragm tissue velocity and transdiaphragmatic twitch pressure

  Through study completion, an average of 6 months

Secondary Outcomes (3)

• 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

Study Arms (1)

Patients with confirmed or suspected diaphragm dysfunction

EXPERIMENTAL

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; Diagnostic Test: EMG

Interventions

Transdiaphragmatic pressure measurement DIAGNOSTIC_TEST

Ultrafast ultrasound imaging of the diaphragm during artificially evoked responses

Also known as: Ultrafast ultrasound imaging

Patients with confirmed or suspected diaphragm dysfunction

EMG DIAGNOSTIC_TEST

Surface electromyography of the diaphragm for phrenic nerve conduction study

Patients with confirmed or suspected diaphragm dysfunction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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

You may not qualify if:

• Known allergy to latex
• Known allergy to Lidocaine or similar product
• Pacemaker
• Guardianship/trusteeship
• Pregnant or nursing women

Sponsors & Collaborators

• Institut de Myologie, France: lead

Study Sites (1)

Département R3S - Hôpital Pitié-Salpêtrière

Paris, 75013, France

RECRUITING

Study Officials

• Damien BACHASSON, PhD

  Institute ofMyology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Damien BACHASSON, PhD

CONTACT

01 42 16 66 43; d.bachasson@institut-myologie.org

Christian STRAUS, Pr

CONTACT

01 42 17 85 74; christian.straus@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 1, 2022
• First Posted: March 3, 2022
• Study Start: May 24, 2023
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)