Positioning and Ultrasound Examination of the Gastric Antrum

May 4, 2018 updated by: Lionel Bouvet, Hôpital Edouard Herriot

Effect of Positioning on Ultrasound Examination of the Gastric Antrum

The aim of this prospective study was to assess the effect of patient positioning on the ultrasound assessment of gastric contents.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69500
        • Hopital Femme Mere Enfant

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA 1 and 2 volunteers

Exclusion Criteria:

  • Diabetes mellitus
  • previous gastrointestinal surgery
  • Medication affecting gastric motility
  • digestive diseases, gastroparesis
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Supine position
patient 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
Behavioral: 6 hours fasting and free oral intake of water
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.
Sham Comparator: 30° semirecumbent position
patient 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
Behavioral: 6 hours fasting and free oral intake of water
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.
Sham Comparator: 45° semirecumbent position
patient 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
Behavioral: 6 hours fasting and free oral intake of water
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.
Sham Comparator: 90° semirecumbent position
patient 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
Behavioral: 6 hours fasting and free oral intake of water
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in ultrasound measurement of the antral cross sectional area according to the position
Time Frame: through study completion, an average of 20 min
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
Time Frame: through study completion, an average of 20 min
qualitative ultrasound assessment of gastric contents
through study completion, an average of 20 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hôpital Edouard Herriot

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 3, 2017

Primary Completion (Actual)

January 20, 2018

Study Completion (Actual)

January 20, 2018

Study Registration Dates

First Submitted

June 28, 2017

First Submitted That Met QC Criteria

June 29, 2017

First Posted (Actual)

July 2, 2017

Study Record Updates

Last Update Posted (Actual)

May 7, 2018

Last Update Submitted That Met QC Criteria

May 4, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • L16-190

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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