Gastric UltrasoundNCT04206111
Evaluation of Gastric Insufflation Measured by Ultrasound of the Antral Surface During Optiflow Preoxygenation
An observational study of Gastric Ultrasound, run by University of Liege at 1 site in Belgium.
Trial summary
Check in gastric ultrasound for lack of stomach insufflation during preoxygenation with high-flow nasal cannulas Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Ultrasound
- What is being tested?
- Preoxygenation
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jun 2020to 1 Oct 2020
- 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
- Adult, Older adult
Study population: Adults
Who may be able to join
- Adults Volunteers
Who cannot join
- History of gastric surgery
- Facial or oropharyngeal abnormality
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Javillier
Liège, 4000
Benjamin Javillier, MD, 003243667180, benjamin.javillier@chuliege.be
About this study
Check in gastric ultrasound for lack of stomach insufflation during preoxygenation with high-flow nasal cannulas
- Conditions
- Gastric Ultrasound
- Being tested
- Preoxygenation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PreoxygenationProcedure or surgery
preoxygenation with high flow nasal cannula at 40l/min for 5min
| Study group | Role | What they receive |
|---|---|---|
| Preoxygenation | Not described Receives: Procedure: Preoxygenation |
What is being measured
The primary outcome is the main question the study is designed to answer.
no gastric insufflation
Number of Participants with no gastric insufflation
Measured: From date of randomization until the date of first documented progression, whichever came first, assessed up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2019
- Study start1 Jun 2020
- Primary completion1 Sep 2020 (estimated)
- Study completion1 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric UltrasoundStudies 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
- 50 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
- NCT04206111
- Sponsor's protocol ID
- Optisafe
- Status last verified
- Jun 2020
- First submitted
- 15 Dec 2019
- Last updated
- 16 Jun 2020
- 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 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Gastric Insufflation Measured by Ultrasound of the Antral Surface During Optiflow Preoxygenation
- ClinicalTrials.gov ID
- NCT04206111
- Acronym / sponsor ID
- Optisafe
- Conditions
- Gastric Ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 20 Dec 2019 (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.
Check in gastric ultrasound for lack of stomach insufflation during preoxygenation with high-flow nasal cannulas
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preoxygenation | – | Procedure: Preoxygenation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adults
Key inclusion criteria (1 listed)
- Adults Volunteers
Key exclusion criteria (2 listed)
- History of gastric surgery
- Facial or oropharyngeal abnormality
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 |
|---|---|---|
| Preoxygenationpreoxygenation with high flow nasal cannula at 40l/min for 5min | Procedure or surgery | Preoxygenation |
Primary outcome
no gastric insufflation
Time frame: From date of randomization until the date of first documented progression, whichever came first, assessed up to 6 months
Number of Participants with no gastric insufflation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Ultrasound, run by University of Liege at 1 site in Belgium.
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 2 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 16 Jun 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 Belgium. 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?
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, benjamin.javillier@chuliege.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
no gastric insufflation (time frame: From date of randomization until the date of first documented progression, whichever came first, assessed up to 6 months). 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 16 Jun 2020.