CT Residual Gastric Fluid Volume

NCT ID: NCT02239068

Last Updated: 2024-01-18

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

Total Enrollment

76 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-28

Study Completion Date

2023-06-01

Brief Summary

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Hypothesis: The investigators hypothesize that more than 50% of the patients receiving enteric contrast material (ECM) \< 2 hours of anesthesia/sedation would have residual gastric fluid volume (GFV) \> 0.4 ml/kg. The investigators also hypothesize that measuring GFV by using region of interest in the CT technique is accurate compared to blind aspiration of the gastric contents with a syringe and a multi-orificed orogastric tube.

Detailed Description

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The purpose of our study is to examine the residual gastric fluid volume when oral contrast is administered within 2 hours of anesthesia /sedation and to validate the accuracy of measuring the residual gastric volume by using region of interest in the CT image by using blind aspiration of the gastric contents with a syringe and a multi-orificed orogastric tube.

Conditions

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Clinical CT Abdomen/Pelvic With Oral Contrast and Sedation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients scheduled for CT abdomen with contrast and require anesthesia/sedation
* Subjects must be 1 month to 10 years of age (inclusive)
* The subject's legally authorized representative has given written informed consent to participate in the study

Exclusion Criteria

* Subjects violate the institution fasting guideline before anesthesia /sedation with the exception of the oral contrast
Minimum Eligible Age

1 Month

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mohamed Mahmoud, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

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Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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2011-0286

Identifier Type: -

Identifier Source: org_study_id

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