Sensitivity and Reproducibility of 18F-fluorodeoxyglucose Positron Emission Tomography for Assessment of Respiratory Muscle Activity

NCT05234099 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-04-10

No results posted yet for this study

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.

Conditions

  • Respiratory Muscle

Interventions

DIAGNOSTIC_TEST

18F-FDG Positron emission tomography - MRI

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

DIAGNOSTIC_TEST

Multiparametric ultrasound imaging

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.

DIAGNOSTIC_TEST

Surface electromyography

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.

DIAGNOSTIC_TEST

Transdiaphragmatic preasure measurmement

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

DIAGNOSTIC_TEST

Magnetic stimulation of the phrenic nerves

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.

DIAGNOSTIC_TEST

Ventilation against inspiratory loading

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.

Sponsors & Collaborators

  • Institut de Myologie, France

    lead OTHER

Principal Investigators

  • Damien Bachasson, PhD · Institute of Myology

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-05
Primary Completion
2023-12-22
Completion
2023-12-22

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05234099 on ClinicalTrials.gov