CT Residual Gastric Fluid Volume

Residual Gastric Fluid With Administering Clear Liquids Within Two Hours of Anesthesia in Children

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 76

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 10 years (Child)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from the Radiology CT schedule.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Residual gastric fluid volume (GFV) < 0.4ml/kg or > 0.4 ml/kg	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.	Approximately 2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Residual gastric fluid volume (GFV) < 0.8 ml/kg or > 0.8 ml/kg	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.	Approximate 2 hours

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Investigators: Principal Investigator: Mohamed Mahmoud, MD, Children's Hospital Medical Center, Cincinnati

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2011
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: July 22, 2014
• First Submitted That Met QC Criteria: September 10, 2014
• First Posted (Estimated): September 12, 2014

Study Record Updates

• Last Update Posted (Estimated): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 16, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: CT, sedation, oral contrast
• Other Study ID Numbers: 2011-0286

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO