Text Size

Bedside Ultrasound Assessment of Gastric Content and Volume

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01151228
First received: June 24, 2010
Last updated: February 8, 2013
Last verified: February 2013
History of Changes

June 24, 2010
February 8, 2013
December 2009
August 2011   (final data collection date for primary outcome measure)
Stomach volume [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01151228 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Bedside Ultrasound Assessment of Gastric Content and Volume
Bedside Ultrasound Assessment of Gastric Content and Volume. Validating a Mathematical Model Using Gastroscopic Examination

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Gastroscopy
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.
  • Placebo Comparator: Zero volume
    Patients will not ingest any apple juice prior to the second ultrasound.
    Intervention: Other: Ultrasound examination followed by ingestion of Apple Juice prior to a second ultrasound procedure, followed by gastroscopic suctioning of stomach content.
  • Experimental: 50 mL
    Patients will ingest 50 mL apple juice prior to the second ultrasound.
    Intervention: Other: Ultrasound examination followed by ingestion of Apple Juice prior to a second ultrasound procedure, followed by gastroscopic suctioning of stomach content.
  • Experimental: 100 mL
    Patients will ingest 100 mL apple juice prior to the second ultrasound.
    Intervention: Other: Ultrasound examination followed by ingestion of Apple Juice prior to a second ultrasound procedure, followed by gastroscopic suctioning of stomach content.
  • Experimental: 200 mL
    Patients will ingest 100 mL apple juice prior to the second ultrasound.
    Intervention: Other: Ultrasound examination followed by ingestion of Apple Juice prior to a second ultrasound procedure, followed by gastroscopic suctioning of stomach content.
  • Experimental: 300 mL
    Patients will ingest 300 mL apple juice prior to the second ultrasound.
    Intervention: Other: Ultrasound examination followed by ingestion of Apple Juice prior to a second ultrasound procedure, followed by gastroscopic suctioning of stomach content.
  • Experimental: 400 mL
    Patients will ingest 400 mL apple juice prior to the second ultrasound.
    Intervention: Other: Ultrasound examination followed by ingestion of Apple Juice prior to a second ultrasound procedure, followed by gastroscopic suctioning of stomach content.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
108
September 2011
August 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01151228
09-0764-BE
No
University Health Network, Toronto
University Health Network, Toronto
Not Provided
Principal Investigator: Anahi Perlas, MD University Health Network, Toronto
University Health Network, Toronto
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP