CT Residual Gastric Fluid Volume

Completed

• Conditions: Clinical CT Abdomen/Pelvic With Oral Contrast and Sedation

• Registration Number: NCT02239068
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-06-28
• Study First Submitted: 2014-07-22
• Study First Submitted QC: 2014-09-10
• Study First Posted: 2014-09-12
• Primary Completion: 2023-06-01
• Study Completion: 2023-06-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-16
• Last Update Posted: 2024-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Residual gastric fluid volume (GFV) < 0.4ml/kg or > 0.4 ml/kg	Approximately 2 hours	Patients will have gastric volume suctioned and measured after the CT scan. The investigator will compare the amount suctioned to the measurement from the actual CT scan when all patients have been enrolled in the study.

Secondary Outcome Measures

Name	Time	Method
Residual gastric fluid volume (GFV) < 0.8 ml/kg or > 0.8 ml/kg	Approximate 2 hours	Patients will have gastric volume suctioned and measured after the CT scan. The investigator will compare the amount suctioned to the measurement from the actual CT scan when all patients have been enrolled in the study.

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States