MRI of the Chest Under High Frequency Ventilation

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer; Non-invasive Ventilation; High-frequency Ventilation
• Intervention / Treatment: Device: MRI with High-frequency non-invasive ventilation; Other: MRI without High-frequency non-invasive ventilation

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Lausanne, Switzerland, 1011
    • University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy subjets : normal respiratory function and no known lung disease
• Age >=18y

Exclusion Criteria:

• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: MRI with HF-NIV; Intervention: Acquisition of MRI with High-Frequency non-invasive ventilation (HF-NIV)	Device: MRI with High-frequency non-invasive ventilation; MRI performed under high-frequency non-invasive ventilation
ACTIVE_COMPARATOR: MRI without HF-NIV; Intervention: MRI without High-Frequency non-invasive ventilation (HF-NIV)	Other: MRI without High-frequency non-invasive ventilation; MRI performed without High-frequency non-invasive ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: University of Lausanne Hospitals
• Investigators: Principal Investigator: Catherine I Beigelman-Aubry, MD, University Hospitals Lausanne Switzerland

Publications and helpful links

General Publications

• 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 Imaging. 2019 Dec;50(6):1789-1797. doi: 10.1002/jmri.26808. Epub 2019 May 28. Erratum In: J Magn Reson Imaging. 2021 Feb;53(2):642.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2016
• Primary Completion (ACTUAL): July 1, 2017
• Study Completion (ACTUAL): July 1, 2017

Study Registration Dates

• First Submitted: November 17, 2016
• First Submitted That Met QC Criteria: November 21, 2016
• First Posted (ESTIMATE): November 25, 2016

Study Record Updates

• Last Update Posted (ACTUAL): March 5, 2020
• Last Update Submitted That Met QC Criteria: March 2, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: MRI; Apnea; Chest
• Other Study ID Numbers: MR-HFV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO