Bedside Ultrasound Assessment of Gastric Content and Volume

NCT ID: NCT01151228

Last Updated: 2013-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Gastroscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Zero volume

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

Group Type PLACEBO_COMPARATOR

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

Intervention Type 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.

50 mL

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

Group Type EXPERIMENTAL

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

Intervention Type 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

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

Group Type EXPERIMENTAL

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

Intervention Type 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.

200 mL

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

Group Type EXPERIMENTAL

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

Intervention Type 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.

300 mL

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

Group Type EXPERIMENTAL

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

Intervention Type 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.

400 mL

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

Group Type EXPERIMENTAL

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

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anahi Perlas, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

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Toronto Western Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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09-0764-BE

Identifier Type: -

Identifier Source: org_study_id

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