Bedside Ultrasound Assessment of Gastric Content and Volume

Gastroscopy Clinical Trial

Official title:

Bedside Ultrasound Assessment of Gastric Content and Volume. Validating a Mathematical Model Using Gastroscopic Examination

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01151228
• Other study ID #: 09-0764-BE
• Status: Completed
• Phase: N/A
• First received: June 24, 2010
• Last updated: February 8, 2013
• Start date: December 2009
• Est. completion date: September 2011

Study information

• Verified date: February 2013
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Research Ethics Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: September 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Gastroscopy

Intervention

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.

Locations

Country	Name	City	State
Canada	Toronto Western Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stomach volume	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.	1 hour	No