Gastric Ultrasound

Surgery Clinical Trial

Official title:

Ultrasonographic Evaluation of Gastric Volume and Contents Before Surgery in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04127331
• Other study ID #: STUDY00000480
• Status: Completed
• Phase: N/A
• Start date: January 10, 2020
• Est. completion date: September 6, 2022

Study information

• Verified date: February 2023
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 6, 2022
• Est. primary completion date: September 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Surgery

Intervention

Device:
• Point-of-Care Ultrasound
Portable ultrasonography done at the bedside.

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Alok Moharir

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	NPO at the Time of Surgery	Amount of time the patient was without food or water prior to their surgery.	Baseline
Secondary	Pre-operative Opioid Administration	Patients who received opioids for pain control prior to surgery.	Baseline