NCT02973373

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 25, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

March 5, 2020

Status Verified

March 1, 2020

Enrollment Period

8 months

First QC Date

November 17, 2016

Last Update Submit

March 2, 2020

Conditions

Non-invasive VentilationHigh-frequency VentilationHealthy Volunteer

Keywords

MRIChestApnea

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Heart and coronary arteries evaluation (soapbubble, signal to noise, contrast to noise)

    within 2 weeks after MRI acquisition

  • Synchronization of the acquisition

    during the MRI examination

  • Subjective tolerance (questionnaire)

    at the end of the MRI examination

Study Arms (2)

MRI with HF-NIV

EXPERIMENTAL

Intervention: Acquisition of MRI with High-Frequency non-invasive ventilation (HF-NIV)

Device: MRI with High-frequency non-invasive ventilation

MRI without HF-NIV

ACTIVE COMPARATOR

Intervention: MRI without High-Frequency non-invasive ventilation (HF-NIV)

Other: MRI without High-frequency non-invasive ventilation

Interventions

MRI with High-frequency non-invasive ventilationDEVICE

MRI performed under high-frequency non-invasive ventilation

MRI with HF-NIV
MRI without High-frequency non-invasive ventilationOTHER

MRI performed without High-frequency non-invasive ventilation

MRI without HF-NIV

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals

Lausanne, 1011, Switzerland

Location

Related 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 Imaging. 2019 Dec;50(6):1789-1797. doi: 10.1002/jmri.26808. Epub 2019 May 28.

    PMID: 31136048RESULT

MeSH Terms

Conditions

Apnea

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Catherine I Beigelman-Aubry, MD

    University Hospitals Lausanne Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 17, 2016

First Posted

November 25, 2016

Study Start

November 1, 2016

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

March 5, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)