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OpenTrials
Completed

NCT Number: NCT05265351

Ultrafast Ultrasound for the Functional Assessment of the Diaphragm

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Département R3S - Hôpital Pitié-Salpêtrière

Paris, 75013, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transdiaphragmatic pressure measurement

Diagnostic Test

Ultrafast ultrasound imaging of the diaphragm during artificially evoked responses

Other names: Ultrafast ultrasound imaging

EMG

Diagnostic Test

Surface electromyography of the diaphragm for phrenic nerve conduction study

Primary outcomes

  1. Significant relationship between maximal diaphragm tissue velocity and transdiaphragmatic twitch pressure

    Time frame: Through study completion, an average of 6 months

Secondary outcomes

  1. Significant relationship between the diaphragm tissue latency and EMG latency

    Time frame: Through study completion, an average of 6 months

  2. Accurate discrimination between patients with or without diaphragm dysfunction using metrics derived from ultrafast ultrasound

    Time frame: Through study completion, an average of 6 months

  3. Accurate discrimination between patients with or without phrenic conduction abnormality using metrics derived from ultrafast ultrasound

    Time frame: Through study completion, an average of 6 months

Sponsors and collaborators

Lead sponsor

Institut de Myologie, France

Other

Registry information

Official study title

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

Acronym: ECHOSTIM-EFR

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 3, 2022
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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