Positioning and Ultrasound Examination of the Gastric Antrum
Effect of Positioning on Ultrasound Examination of the Gastric Antrum
1 other identifier
interventional
25
1 country
1
Brief Summary
The aim of this prospective study was to assess the effect of patient positioning on the ultrasound assessment of gastric contents.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2017
Shorter than P25 for not_applicable
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
First Submitted
Initial submission to the registry
June 28, 2017
CompletedFirst Posted
Study publicly available on registry
July 2, 2017
CompletedStudy Start
First participant enrolled
July 3, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 20, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 20, 2018
CompletedMay 7, 2018
May 1, 2018
7 months
June 28, 2017
May 4, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Change in ultrasound measurement of the antral cross sectional area according to the position
Ultrasound measurement of antral cross-sectional area
through study completion, an average of 20 min
Change in qualitative ultrasound assessment of gastric contents according to the position
qualitative ultrasound assessment of gastric contents
through study completion, an average of 20 min
Study Arms (4)
Supine position
SHAM COMPARATORpatient in supine position, lying on the back, turned in the right lateral decubitus and turned in the left lateral decubitus in a randomized way, after prolonged fasting and 10 min after free oral intake of water
30° semirecumbent position
SHAM COMPARATORpatient in semirecumbent position (head of the bed elevated to 30°), lying on the back, turned in the right lateral decubitus and turned in the left lateral decubitus in a randomized way, after prolonged fasting and 10 min after free oral intake of water
45° semirecumbent position
SHAM COMPARATORpatient in semirecumbent position (head of the bed elevated to 45°), lying on the back, turned in the right lateral decubitus and turned in the left lateral decubitus in a randomized way, after prolonged fasting and 10 min after free oral intake of water
90° semirecumbent position
SHAM COMPARATORpatient in semirecumbent position (head of the bed elevated to 90°), lying on the back, after prolonged fasting and 10 min after free oral intake of water
Interventions
Ultrasound examination of the gastric antrum are performed in volunteers after prolonged fasting and 10 min after oral intake of water. Volunteer should be lying on his/her back, right lateral decubitus position and left lateral decubitus position with randomization of the order.
Eligibility Criteria
You may qualify if:
- ASA 1 and 2 volunteers
You may not qualify if:
- Diabetes mellitus
- previous gastrointestinal surgery
- Medication affecting gastric motility
- digestive diseases, gastroparesis
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital Femme Mère Enfant
Lyon, 69500, France
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
June 28, 2017
First Posted
July 2, 2017
Study Start
July 3, 2017
Primary Completion
January 20, 2018
Study Completion
January 20, 2018
Last Updated
May 7, 2018
Record last verified: 2018-05