NCT04735276

Brief Summary

HFNO CAN BE USED AS A PREOXYGENATION TECHNIQUE BUT IS IT A SAFE TECHNIQUE IN TERMS OF GASTRIC INSUFFLATION?

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

January 25, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 3, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
Last Updated

February 3, 2021

Status Verified

January 1, 2021

Enrollment Period

2 months

First QC Date

January 25, 2021

Last Update Submit

January 30, 2021

Conditions

MRI

Outcome Measures

Primary Outcomes (1)

  • Measurement of the antero-posterior and cranio-caudal diameters of the gastric antrum

    surface of the gastric antrum

    through study completion, an average of 1 year

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

healthy adult volunteers

You may qualify if:

  • Adults Volunteers

You may not qualify if:

  • Pregnancy
  • Claustrophobia
  • Gastric surgery
  • Gastric pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Benjamin Javillier, MD

CONTACT

003243667180javillier.benjamin@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 25, 2021

First Posted

February 3, 2021

Study Start

April 1, 2021

Primary Completion

May 30, 2021

Study Completion

August 30, 2021

Last Updated

February 3, 2021

Record last verified: 2021-01