NCT05234099

Brief Summary

The assessment of respiratory muscle function is critical within both clinical and research settings. Tools for the assessment of respiratory muscle function are especially useful in diagnosing, phenotyping, understanding pathophysiology, and assessing treatment responses in patients with respiratory symptoms, including critically hill patients and patients with respiratory and/or neuromuscular diseases. Respiratory muscle function is most commonly assessed using flow (i.e. spirometry) and pressure measurements during spontaneous ventilation, voluntary respiratory efforts, or artificially evoked responses using magnetic or electrical stimulation. Some of these approaches may be limited within patients suffering from neuromuscular diseases. The study hypothesis is the 18F-FDG PET technology, heavily used for clinical oncology purposes (diagnostic, staging, response to treatment, prognosis), could be an interesting alternative to invasive measurement of the respiratory muscle activity. In addition, it may contribute to further validate metrics based on multiparametric ultrasound imaging.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 10, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

May 5, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2023

Completed
Last Updated

April 10, 2024

Status Verified

April 1, 2024

Enrollment Period

1.6 years

First QC Date

February 1, 2022

Last Update Submit

April 9, 2024

Conditions

Respiratory Muscle

Outcome Measures

Primary Outcomes (1)

  • Correlation between multiparametric ultrasound and 18F-FDG PET-MRI during respiratory muscle activity measurement

    Existence of a significant correlation between the variables derived from the multiparametric ultrasound and the work of the respiratory muscles induced by the ventilatory spot assessed by 18F-FDG PET-MRI

    Through study completion, on average 3 weeks

Secondary Outcomes (2)

  • Significant correlation between measurements of respiratory muscle activity assessed by pressure measurements and increased respiratory muscle work induced by the ventilation against inspiratory loading as assessed by 18F-FDG PET-MRI

    Through study completion, on average 3 weeks

  • Significant correlation between measures of respiratory muscle activity assessed by sEMG and respiratory muscle work induced by the ventilation against inspiratory loading as assessed by 18F-FDG PET-MRI

    Through study completion, on average 3 weeks

Study Arms (1)

Control subjects

EXPERIMENTAL

Visit 1 (V1) (Duration: 2.5h) * Information, verification of inclusion and exclusion criteria, information note. * Consent form. * Location of the diaphragm and parasternal intercostal muscle using ultrasound. * Measurements at rest (mouth pressures, sEMG, ultrasound imaging). * Injection of 3 MBq/kg of 18F-FDG. * 1h resting period. * 18F-FDG PET-MRI scan. Visit 2 (V2) 3-10 days after V1 (Duration: 3h) * Location of the diaphragm and parasternal intercostal muscle. * Measurements at rest (mouth pressures, sEMG, ultrasound imaging) * Magnetic stimulation of the phrenic nerves * Ventilation against inspiratory loading * Magnetic stimulation of the phrenic nerves * Injection of 3 MBq/kg of 18F-FDG * 1h resting period * 18F-FDG PET-MRI scan Visit 3 (V3) 3-10 days after V2 (Duration: 3h) \- Identical to visit 2

Diagnostic Test: 18F-FDG Positron emission tomography - MRIDiagnostic Test: Multiparametric ultrasound imagingDiagnostic Test: Surface electromyographyDiagnostic Test: Transdiaphragmatic preasure measurmementDiagnostic Test: Magnetic stimulation of the phrenic nervesDiagnostic Test: Ventilation against inspiratory loading

Interventions

18F-FDG Positron emission tomography - MRIDIAGNOSTIC_TEST

All the examinations will be performed in the supine position on the same integrated 3T PET-MRI scanner

Control subjects
Multiparametric ultrasound imagingDIAGNOSTIC_TEST

Acquisitions of respiratory muscles (diaphragm, intercostal muscles) will be performed using two 6 MHz central frequency linear transducer (SL 10-2) driven by two identical ultrafast ultrasound devices.

Control subjects
Surface electromyographyDIAGNOSTIC_TEST

sEMG recordings will be performed in the left side on the sternocleidomastoid muscle, the intercostal parasternal muscle, and the external oblique muscle using pairs of 20-mm-diameter silver chloride surface electrodes.

Also known as: sEMG
Control subjects
Transdiaphragmatic preasure measurmementDIAGNOSTIC_TEST

Esophageal and gastric pressures will be measured using 8-cm balloon-catheters.

Also known as: Internal respiratory pressures measurements
Control subjects
Magnetic stimulation of the phrenic nervesDIAGNOSTIC_TEST

In order to quantify the contractile fatigue in diaphragm induced by the ventilatory task (described below), we will use bilateral anterior magnetic stimulation of the phrenic nerves using two Magstim 200 stimulator.

Control subjects
Ventilation against inspiratory loadingDIAGNOSTIC_TEST

A POWERbreathe KH2 device (POWERbreathe International Ltd) will be connected on the inspiratory side of the two-way valve. Level of inspiratory loading will be randomized in order to produce different amounts of muscle work in each subject.

Control subjects

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 yo
  • Non-smoker
  • Signed informed consent
  • Affiliate or beneficiary of a social security scheme
  • Pregnant or breastfeeding women
  • Respiratory, cardiovascular, metabolic, neuromuscular pathologies
  • Claustrophobia
  • Belonephobia
  • Latex allergy
  • Persons subject to a legal protection measure or unable to express their consent
  • Contraindications to MRI (claustrophobia, metal implants)
  • Inability to participate in the study
  • Inability to comply with protocol requirements

You may not qualify if:

  • Blood sugar\> 1.8 g / L (V1, V2, V3)
  • Impossibility of inserting the esophageal and / or gastric tubes (V2, V3)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Service hospitalier Fréderic Joliot

Orsay, 91400, France

Location

Association Institut de Myologie

Paris, 75013, France

Location

MeSH Terms

Interventions

Electromyography

Intervention Hierarchy (Ancestors)

ElectrodiagnosisDiagnostic Techniques and ProceduresDiagnosisMyography

Study Officials

  • Damien Bachasson, PhD

    Institute of Myology

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 1, 2022

First Posted

February 10, 2022

Study Start

May 5, 2022

Primary Completion

December 22, 2023

Study Completion

December 22, 2023

Last Updated

April 10, 2024

Record last verified: 2024-04

Locations

FR(2)