Non-invasive VentilationNCT02973373
MRI of the Chest Under High Frequency Ventilation
A study testing MRI with High-frequency non-invasive ventilation and MRI without High-frequency non-invasive ventilation in people with Non-invasive Ventilation and High-frequency Ventilation, run by University of Lausanne Hospitals at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Non-invasive Ventilation, High-frequency Ventilation, Healthy Volunteer
- What is being tested?
- MRI with High-frequency non-invasive ventilation and MRI without High-frequency non-invasive ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2016to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjets : normal respiratory function and no known lung disease
- Age >=18y
Who cannot join
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- MRI with High-frequency non-invasive ventilation, MRI without High-frequency non-invasive ventilation
- Keywords
- MRI, Chest, Apnea
- Medical subject headings
- Apnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI with High-frequency non-invasive ventilationDevice
MRI performed under high-frequency non-invasive ventilation
MRI without High-frequency non-invasive ventilationOther
MRI performed without High-frequency non-invasive ventilation
| Study group | Role | What they receive |
|---|---|---|
| MRI with HF-NIV | Experimental | Intervention: Acquisition of MRI with High-Frequency non-invasive ventilation (HF-NIV) Receives: Device: MRI with High-frequency non-invasive ventilation |
| MRI without HF-NIV | Active comparator | Intervention: MRI without High-Frequency non-invasive ventilation (HF-NIV) Receives: Other: MRI without High-frequency non-invasive ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 2 weeks after MRI acquisition
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: at the end of the MRI examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-invasive VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beigelman-Aubry Catherine, University of Lausanne Hospitals
- Investigators
- Catherine I Beigelman-Aubry, MD, Principal investigator, University Hospitals Lausanne Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02973373
- Sponsor's protocol ID
- MR-HFV
- Status last verified
- Mar 2020
- First submitted
- 17 Nov 2016
- Last updated
- 5 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 31136048
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI of the Chest Under High Frequency Ventilation
- ClinicalTrials.gov ID
- NCT02973373
- Acronym / sponsor ID
- MR-HFV
- Keywords
- MRI, Chest, Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 25 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MRI with HF-NIV | Experimental | Device: MRI with High-frequency non-invasive ventilationIntervention: Acquisition of MRI with High-Frequency non-invasive ventilation (HF-NIV) |
| MRI without HF-NIV | Active comparator | Other: MRI without High-frequency non-invasive ventilationIntervention: MRI without High-Frequency non-invasive ventilation (HF-NIV) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy subjets : normal respiratory function and no known lung disease
- Age >=18y
Key exclusion criteria (1 listed)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI with High-frequency non-invasive ventilationMRI performed under high-frequency non-invasive ventilation | Device | MRI with HF-NIV |
| MRI without High-frequency non-invasive ventilationMRI performed without High-frequency non-invasive ventilation | Other | MRI without HF-NIV |
Primary outcome
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.
3 secondary outcomes
Heart and coronary arteries evaluation (soapbubble, signal to noise, contrast to noise)
Time frame: within 2 weeks after MRI acquisition
Synchronization of the acquisition
Time frame: during the MRI examination
Subjective tolerance (questionnaire)
Time frame: at the end of the MRI examination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2020.
- Results publication: PubMed 31136048Delacoste 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine I Beigelman-Aubry, MD principal investigator
University Hospitals Lausanne Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI with High-frequency non-invasive ventilation and MRI without High-frequency non-invasive ventilation in people with Non-invasive Ventilation and High-frequency Ventilation, run by University of Lausanne Hospitals at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Image quality assessment (soapbubble, maximum of first derivative, signal to noise, contrast to noise) (time frame: within 2 weeks after MRI acquisition). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02973373, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2020.