Bedside Ultrasound Assessment of Gastric Content and Volume

Sponsor
University Health Network, Toronto (Other)
Overall Status
Completed
CT.gov ID
NCT01151228
Collaborator
(none)
108
1
6
21
5.1

Study Details

Study Description

Brief Summary

Patients undergoing gastroscopy will undergo two pre-procedure ultrasound scans of the stomach, once on arrival in the unit and on an empty stomach and a second time after consumption of a randomized amount of apple juice (0, 50, 100, 200, 300 or 400 mL). Immediately after ingestion and the second ultrasound scan, subjects will have their gastroscopy which will start by suctioning out the apple juice. Measurements of stomach fluid volume conducted by ultrasound will be compared to the actual volume removed during the gastroscopy procedure.

Condition or Disease Intervention/Treatment Phase
  • Other: Ultrasound examination followed by ingestion of Apple Juice prior to a second ultrasound procedure, followed by gastroscopic suctioning of stomach content.
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
108 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Care Provider, Investigator, Outcomes Assessor)
Official Title:
Bedside Ultrasound Assessment of Gastric Content and Volume. Validating a Mathematical Model Using Gastroscopic Examination
Study Start Date :
Dec 1, 2009
Actual Primary Completion Date :
Aug 1, 2011
Actual Study Completion Date :
Sep 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Zero volume

Patients will not ingest any apple juice prior to the second ultrasound.

Other: Ultrasound examination followed by ingestion of Apple Juice prior to a second ultrasound procedure, followed by gastroscopic suctioning of stomach content.
Ultrasound scan of the stomach followed by ingestion of 0, 50, 100, 200, 300, or 400 mL of apple juice, followed by second ultrasound scan of the stomach, followed by gastroscopic suctioning of stomach content.

Experimental: 50 mL

Patients will ingest 50 mL apple juice prior to the second ultrasound.

Other: Ultrasound examination followed by ingestion of Apple Juice prior to a second ultrasound procedure, followed by gastroscopic suctioning of stomach content.
Ultrasound scan of the stomach followed by ingestion of 0, 50, 100, 200, 300, or 400 mL of apple juice, followed by second ultrasound scan of the stomach, followed by gastroscopic suctioning of stomach content.

Experimental: 100 mL

Patients will ingest 100 mL apple juice prior to the second ultrasound.

Other: Ultrasound examination followed by ingestion of Apple Juice prior to a second ultrasound procedure, followed by gastroscopic suctioning of stomach content.
Ultrasound scan of the stomach followed by ingestion of 0, 50, 100, 200, 300, or 400 mL of apple juice, followed by second ultrasound scan of the stomach, followed by gastroscopic suctioning of stomach content.

Experimental: 200 mL

Patients will ingest 100 mL apple juice prior to the second ultrasound.

Other: Ultrasound examination followed by ingestion of Apple Juice prior to a second ultrasound procedure, followed by gastroscopic suctioning of stomach content.
Ultrasound scan of the stomach followed by ingestion of 0, 50, 100, 200, 300, or 400 mL of apple juice, followed by second ultrasound scan of the stomach, followed by gastroscopic suctioning of stomach content.

Experimental: 300 mL

Patients will ingest 300 mL apple juice prior to the second ultrasound.

Other: Ultrasound examination followed by ingestion of Apple Juice prior to a second ultrasound procedure, followed by gastroscopic suctioning of stomach content.
Ultrasound scan of the stomach followed by ingestion of 0, 50, 100, 200, 300, or 400 mL of apple juice, followed by second ultrasound scan of the stomach, followed by gastroscopic suctioning of stomach content.

Experimental: 400 mL

Patients will ingest 400 mL apple juice prior to the second ultrasound.

Other: Ultrasound examination followed by ingestion of Apple Juice prior to a second ultrasound procedure, followed by gastroscopic suctioning of stomach content.
Ultrasound scan of the stomach followed by ingestion of 0, 50, 100, 200, 300, or 400 mL of apple juice, followed by second ultrasound scan of the stomach, followed by gastroscopic suctioning of stomach content.

Outcome Measures

Primary Outcome Measures

  1. Stomach volume [1 hour]

    Fluid volume in the stomach after ingestion of apple juice will be compared between measurements done with ultrasound vs direct suctioning of fluid from the stomach.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Age 18-80 years

  • Weight 50-100 kg

  • height greater than 150 cm

  • ability to provide informed consent

Exclusion Criteria:
  • recent upper GI bleed (within 1 month)

  • previous lower esophageal or gastric surgery

  • not fasted for 8 hours

Contacts and Locations

Locations

Site City State Country Postal Code
1 Toronto Western Hospital Toronto Ontario Canada M5T 2S8

Sponsors and Collaborators

  • University Health Network, Toronto

Investigators

  • Principal Investigator: Anahi Perlas, MD, University Health Network, Toronto

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01151228
Other Study ID Numbers:
  • 09-0764-BE
First Posted:
Jun 28, 2010
Last Update Posted:
Feb 11, 2013
Last Verified:
Feb 1, 2013
Keywords provided by University Health Network, Toronto

Study Results

No Results Posted as of Feb 11, 2013