Healthy Volunteer Clinical Trial
Official title:
MRI of the Chest Under High Frequency Ventilation
NCT number | NCT02973373 |
Other study ID # | MR-HFV |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 2016 |
Est. completion date | July 2017 |
Verified date | March 2020 |
Source | University of Lausanne Hospitals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of the study is to evaluate the benefit on image quality of MRI of the chest performed under high frequency non-invasive ventilation. This technique indeed allows to generate an apnea duration of several minutes with acquisitions performed at full inspiration. This study will be applied on healthy subjects.
Status | Completed |
Enrollment | 10 |
Est. completion date | July 2017 |
Est. primary completion date | July 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Healthy subjets : normal respiratory function and no known lung disease - Age >=18y Exclusion Criteria: • Pregnancy |
Country | Name | City | State |
---|---|---|---|
Switzerland | University Hospitals | Lausanne |
Lead Sponsor | Collaborator |
---|---|
University of Lausanne Hospitals |
Switzerland,
Delacoste J, Dournes G, Dunet V, Ogna A, Noirez L, Simons J, Long O, Berchier G, Stuber M, Lovis A, Beigelman-Aubry C. Ultrashort echo time imaging of the lungs under high-frequency noninvasive ventilation: A new approach to lung imaging. J Magn Reson Ima — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Image quality assessment (soapbubble, maximum of first derivative, signal to noise, contrast to noise) | Image quality and artefacts will be evaluated and compared without and with the device. Sharpness of the interfaces between vessels and lung will be evaluated with the Soapbubble software (Etienne et al., Magn Reson Med. 2002 Oct;48(4):658-66). The interface between diaphragm and lung will be evaluated with the maximum of the first derivative (Tibiletti et al., Magn Reson Med. 2016 Mar;75(3):1324-32). Signal to noise and contrast to noise will be measured within regions of interest in the image. | within 2 weeks after MRI acquisition | |
Secondary | Heart and coronary arteries evaluation (soapbubble, signal to noise, contrast to noise) | The potential benefit on the exploration of the heart and coronary arteries will be assessed. Sharpness of the coronary arteries with respect to the neighbouring tissue will be evaluated with the Soapbubble software (Etienne et al., Magn Reson Med. 2002 Oct;48(4):658-66). Signal to noise and contrast to noise will be measured within regions of interest in the image. | within 2 weeks after MRI acquisition | |
Secondary | Synchronization of the acquisition | The possibility of synchronizing the MRI acquisition with the ventilation system will be explored with the aim to eliminate residual diaphragmatic motion and evaluate the potential additional benefit in terms of image quality and artefacts will be evaluated. | during the MRI examination | |
Secondary | Subjective tolerance (questionnaire) | Subjective tolerance of MRI examination under HF-NIV (questionnaire). Participants will fill the questionnaire right after the examination end. | at the end of the MRI examination |
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