Gastric Ultrasound

Ultrasonographic Evaluation of Gastric Volume and Contents Before Surgery in Children

The primary objective of this study is to evaluate gastric volume and contents as well as gall bladder size in patients scheduled for routine, urgent, and emergency surgery. The hypothesis is that patients with stress, pain and opioid administration will have delayed gastric emptying and therefore a larger gastric fluid volume than those scheduled for elective surgery. The patients who have an appropriate NPO time will have a larger gallbladder size than the patients with shorter NPO time.

Study Overview

• Status: Completed
• Conditions: Surgery
• Intervention / Treatment: Device: Point-of-Care Ultrasound

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Catherine Roth; Phone Number: 6147222997; Email: catherine.roth@nationwidechildrens.org

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ASA 1-3 patients aged 2-18 years of scheduled for elective, urgent, or emergent surgery under general anesthesia.

Exclusion Criteria:

• History of upper gastro-intestinal surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Routine; Patients who are scheduled for routine outpatient surgery.	Device: Point-of-Care Ultrasound; Portable ultrasonography done at the bedside.
Active Comparator: Urgent; Patients who are scheduled for urgent surgery.	Device: Point-of-Care Ultrasound; Portable ultrasonography done at the bedside.
Active Comparator: Emergent; Patients who are scheduled for emergency surgery.	Device: Point-of-Care Ultrasound; Portable ultrasonography done at the bedside.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aspiration Risk Grade	Grade 0: No fluid visible in the gastric antrum Grade 1: Clear fluid visualized with volume < 1.5 mL/kg Grade 2: Clear fluid visualized with volume > 1.5 mL/kg (High risk of aspiration)	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NPO at the Time of Injury	Amount of time the patient was without food or water prior to their injury. This only applies to the Semi-urgent and Urgent groups.	Baseline
NPO at the Time of Surgery	Amount of time the patient was without food or water prior to their surgery.	Baseline
Pre-operative Opioid Administration	Patients who received opioids for pain control prior to surgery.	Baseline

Collaborators and Investigators

• Sponsor: Alok Moharir

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2020
• Primary Completion (Actual): September 6, 2022
• Study Completion (Actual): September 6, 2022

Study Registration Dates

• First Submitted: October 14, 2019
• First Submitted That Met QC Criteria: October 14, 2019
• First Posted (Actual): October 15, 2019

Study Record Updates

• Last Update Posted (Estimated): November 21, 2023
• Last Update Submitted That Met QC Criteria: February 9, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00000480

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No