MRI of the Chest Under High Frequency Ventilation

Healthy Volunteer Clinical Trial

Official title:

MRI of the Chest Under High Frequency Ventilation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02973373
• Other study ID #: MR-HFV
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Est. completion date: July 2017

Study information

• Verified date: March 2020
• Source: University of Lausanne Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

High frequency ventilation (HF-V) has been applied by using a non-invasive interface allowing to obtain a prolonged apnea in awaken subjects. Such an application should be of interest for MRI taking into account its susceptibility to motion of the chest and the imperfect techniques of respiratory gating that are usually performed at end expiration. The purpose of this study is to assess the benefit on image quality of different sequences performed with and without the device in healthy subjects.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Healthy Volunteer
• High-frequency Ventilation
• Non-invasive Ventilation

Intervention

Device:
• MRI with High-frequency non-invasive ventilation
MRI performed under high-frequency non-invasive ventilation

Other:
• MRI without High-frequency non-invasive ventilation
MRI performed without High-frequency non-invasive ventilation

Locations

Country	Name	City	State
Switzerland	University Hospitals	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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

Outcome

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