NCT03378583

Brief Summary

Evaluation of a new method to prevent gastric insufflation

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

March 22, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 14, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 20, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

December 20, 2017

Status Verified

December 1, 2017

Enrollment Period

11 months

First QC Date

December 14, 2017

Last Update Submit

December 14, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • gastric volume

    With the patients in supine position, a curvilinear transducer (Applio XG iStyle Toshiba with an 8-5 MHz) will be placed on the epigastrium in a paramedian sagittal orientation to identify the antrum. The cross-sectional area of the antrum will be measured at the level where both the aorta and upper mesenteric artery will be visible

    within 10 min of induction of anesthesia

Secondary Outcomes (1)

  • diameter of the esophagus

    within 10 min of induction of anesthesia

Study Arms (3)

control,

control normal ventilation

sellick,

ventilation while sellick manoeuvre is applied

low paratracheal esophagus compression

ventilation while low paratracheal esophagus compression is applied

Eligibility Criteria

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

patients undergoing anesthesia under general anesthesia

You may qualify if:

  • elective surgery under general anesthesia

You may not qualify if:

  • body mass index above 35 meeting criteria for difficult ventilation and /or intubation risk for aspiration or gastric surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Liege

Liège, Liege, 4000, Belgium

RECRUITING

Central Study Contacts

Jean François Brichant, MD, PhD

CONTACT

Philippe Gautier, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair of department of anesthesia and intensive care medicine

Study Record Dates

First Submitted

December 14, 2017

First Posted

December 20, 2017

Study Start

March 22, 2017

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

December 20, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations