ClinicalTrials.gg
CompletedNCT01151228Updated Feb 11, 2013

Bedside Ultrasound Assessment of Gastric Content and Volume

An interventional study of Ultrasound examination followed by ingestion of Apple Juice prior to a second ultrasound procedure, followed by gastroscopic suctioning of stomach content. in Gastroscopy, sponsored by University Health Network, Toronto. Completed at 1 site in Canada. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2013-02-11.

Sponsored by University Health Network, Toronto · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
108
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Gastroscopy

Keywords

  • gastroscopy
  • ultrasound
  • stomach volume
  • patients having gastroscopy
03

In context

Lead sponsor

University Health Network, Toronto is the lead sponsor of 1,434 studies on the registry; 293 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • recent upper GI bleed (within 1 month)
  • previous lower esophageal or gastric surgery
  • not fasted for 8 hours
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Care provider, Investigator, Outcomes assessor)
Enrollment
108 participants (actual)

Study arms

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

Interventions

  • OtherUltrasound 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.

06

What researchers measure

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.

    Time frame: 1 hour

07

Study locations

1 site
  • Toronto Western Hospital
    Toronto, Ontario M5T 2S8, Canada
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Dec 2009, a primary completion of Aug 2011 and a completion of Sep 2011. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 24, 2010
First posted
Jun 28, 2010
Start
Dec 2009
Primary completionActual
Aug 2011
CompletionActual
Sep 2011
Last update
Feb 11, 2013
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 11, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01151228
Responsible party
Sponsor
First posted
Jun 28, 2010
Start date
Dec 2009
Primary completion
Aug 2011
Completion
Sep 2011
Last update
Feb 11, 2013

Study contacts

Anahi Perlas, MD
principal investigator · University Health Network, Toronto

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

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