Gastric Ultrasound

Not Applicable

Completed

• Conditions: Surgery
• Interventions: Device: Point-of-Care Ultrasound

• Registration Number: NCT04127331
• Lead Sponsor: Alok Moharir

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-14
• Study First Submitted QC: 2019-10-14
• Study First Posted: 2019-10-15
• Study Start: 2020-01-10
• Primary Completion: 2022-09-06
• Study Completion: 2022-09-06
• Status Verified: 2023-02
• Results First Submitted: 2023-02-09
• Results First Submitted QC: 2023-02-09
• Last Update Submitted: 2023-02-09
• Results First Posted: 2023-11-21
• Last Update Posted: 2023-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Urgent	Point-of-Care Ultrasound	Patients who are scheduled for urgent surgery.
Routine	Point-of-Care Ultrasound	Patients who are scheduled for routine outpatient surgery.
Emergent	Point-of-Care Ultrasound	Patients who are scheduled for emergency surgery.

Primary Outcome Measures

Name	Time	Method
Aspiration Risk Grade	Baseline	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)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States