MRINCT04735276
MRI Study of the Gastric Insufflation After High-flow Nasal Oxygen (HFNO)
An observational study of MRI, run by University of Liege.
Trial summary
HFNO CAN BE USED AS A PREOXYGENATION TECHNIQUE BUT IS IT A SAFE TECHNIQUE IN TERMS OF GASTRIC INSUFFLATION? Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- MRI
- What is being tested?
- HFNO for 5 min
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2021to 30 Aug 2021
- Phase
- Observational
- 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
Study population: healthy adult volunteers
Who may be able to join
- Adults Volunteers
Who cannot join
- Pregnancy
- Claustrophobia
- Gastric surgery
- Gastric pathology
Trial locations and contacts
No sites are listed yet.
About this study
HFNO CAN BE USED AS A PREOXYGENATION TECHNIQUE BUT IS IT A SAFE TECHNIQUE IN TERMS OF GASTRIC INSUFFLATION?
Read the detailed description
The objective of this study is to evaluate by MRI whether the stomach is insufflated during HFNO use in healthy volunteers.
- Conditions
- MRI
- Being tested
- HFNO for 5 min
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HFNO for 5 minDevice
1st basic MRI then HFNO for 5 min with mouth closed breathing and 2nd MRI. Analysis of the surface of the gastric antrum.
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the antero-posterior and cranio-caudal diameters of the gastric antrum
surface of the gastric antrum
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start1 Apr 2021 (estimated)
- Primary completion30 May 2021 (estimated)
- Study completion30 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MRIStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Javillier, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04735276
- Sponsor's protocol ID
- Optirm
- Status last verified
- Jan 2021
- First submitted
- 25 Jan 2021
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI Study of the Gastric Insufflation After High-flow Nasal Oxygen (HFNO)
- ClinicalTrials.gov ID
- NCT04735276
- Acronym / sponsor ID
- Optirm
- Conditions
- MRI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 30 May 2021 (estimated)
- Study completion
- 30 Aug 2021 (estimated)
- First posted
- 3 Feb 2021 (actual)
- 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.
HFNO CAN BE USED AS A PREOXYGENATION TECHNIQUE BUT IS IT A SAFE TECHNIQUE IN TERMS OF GASTRIC INSUFFLATION?
Detailed description
The objective of this study is to evaluate by MRI whether the stomach is insufflated during HFNO use in healthy volunteers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- healthy adult volunteers
Key inclusion criteria (1 listed)
- Adults Volunteers
Key exclusion criteria (4 listed)
- Pregnancy
- Claustrophobia
- Gastric surgery
- Gastric pathology
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 |
|---|---|---|
| HFNO for 5 min1st basic MRI then HFNO for 5 min with mouth closed breathing and 2nd MRI. Analysis of the surface of the gastric antrum. | Device | – |
Primary outcome
Measurement of the antero-posterior and cranio-caudal diameters of the gastric antrum
Time frame: through study completion, an average of 1 year
surface of the gastric antrum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of MRI, run by University of Liege.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Benjamin Javillier, MD (003243667180, javillier.benjamin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of the antero-posterior and cranio-caudal diameters of the gastric antrum (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Feb 2021.