Prevention of Gastric Insufflation During Positive Pressure Ventilation ?
Is Ultrasound-guided Left Paratracheal Esophagus Pressure More Effective Than Cricoid Pressure to Prevent Gastric Insufflation During Positive Pressure Ventilation ?
1 other identifier
observational
90
1 country
1
Brief Summary
Evaluation of a new method to prevent gastric insufflation
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2017
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 22, 2017
CompletedFirst Submitted
Initial submission to the registry
December 14, 2017
CompletedFirst Posted
Study publicly available on registry
December 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2018
CompletedDecember 20, 2017
December 1, 2017
11 months
December 14, 2017
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
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
Central Study Contacts
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