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Completed

NCT Number: NCT02973373

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals

Lausanne, 1011, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Pregnancy

Treatment and study plan

MRI with High-frequency non-invasive ventilation

Device

MRI performed under high-frequency non-invasive ventilation

MRI without High-frequency non-invasive ventilation

Other

MRI performed without High-frequency non-invasive ventilation

Primary outcomes

  1. Image quality assessment (soapbubble, maximum of first derivative, signal to noise, contrast to noise)

    Time frame: within 2 weeks after MRI acquisition

    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.

Secondary outcomes

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

    Time frame: within 2 weeks after MRI acquisition

    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.

  2. Synchronization of the acquisition

    Time frame: during the MRI examination

    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.

  3. Subjective tolerance (questionnaire)

    Time frame: at the end of the MRI examination

    Subjective tolerance of MRI examination under HF-NIV (questionnaire). Participants will fill the questionnaire right after the examination end.

Sponsors and collaborators

Lead sponsor

University of Lausanne Hospitals

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 25, 2016
Registry last updated
Mar 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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