Bedside Ultrasound Assessment of Gastric Content and Volume

NCT01151228 | Completed

• 1 other identifier: 09-0764-BE
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroscopy

Keywords

gastroscopy; ultrasound; stomach volume; patients having gastroscopy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (6)

Zero volume

PLACEBO COMPARATOR

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.

50 mL

EXPERIMENTAL

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.

100 mL

EXPERIMENTAL

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.

200 mL

EXPERIMENTAL

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.

300 mL

EXPERIMENTAL

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.

400 mL

EXPERIMENTAL

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.

Interventions

Ultrasound examination followed by ingestion of Apple Juice prior to a second ultrasound procedure, followed by gastroscopic suctioning of stomach content. OTHER

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.

100 mL; 200 mL; 300 mL; 400 mL; 50 mL; Zero volume

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years
• Weight 50-100 kg
• height greater than 150 cm
• ability to provide informed consent

You may not qualify if:

• recent upper GI bleed (within 1 month)
• previous lower esophageal or gastric surgery
• not fasted for 8 hours

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Study Officials

• Anahi Perlas, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2010
• First Posted: June 28, 2010
• Study Start: December 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: September 1, 2011
• Last Updated: February 11, 2013

Record last verified: 2013-02

Locations

CA (1)