NCT04127331

Gastric Ultrasound

Completed NA Results posted Last updated 21 November 2023

What this trial tests

NA trial testing Point-of-Care Ultrasound in Surgery in 100 participants. Completed in 6 September 2022.

Timeline

10 January 2020

Primary endpoint
6 September 2022

6 September 2022

Quick facts

Lead sponsor	Alok Moharir
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	100
Start date	10 January 2020
Primary completion	6 September 2022
Estimated completion	6 September 2022
Sites	1 location across United States

Drugs / interventions tested

• Point-of-Care Ultrasound

Conditions studied

• Surgery — all drugs for Surgery →

Sponsor

Alok Moharir

Who can join

Adults 2 to 18, any sex, with Surgery. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Aspiration Risk Grade Primary · 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)

0

Group	Value	95% CI
Elective	30
Semi-urgent	30
Urgent	20

1

Group	Value	95% CI
Elective	9
Semi-urgent	2
Urgent	6

Solid (High risk)

Group	Value	95% CI
Elective	1
Semi-urgent	0
Urgent	0

Inconclusive

Group	Value	95% CI
Elective	1
Semi-urgent	0
Urgent	1

NPO at the Time of Injury Secondary · 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.

< 8 hours

Group	Value	95% CI
Semi-urgent	1
Urgent	6

> 8 hours

Group	Value	95% CI
Semi-urgent	5
Urgent	22

NPO at the Time of Surgery Secondary · Baseline

Amount of time the patient was without food or water prior to their surgery.

< 8 hours

Group	Value	95% CI
Elective	2
Semi-urgent	1
Urgent	2

> 8 hours

Group	Value	95% CI
Elective	39
Semi-urgent	31
Urgent	25

Pre-operative Opioid Administration Secondary · Baseline

Patients who received opioids for pain control prior to surgery.

Group	Value	95% CI
Elective	0
Semi-urgent	5
Urgent	11

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Preoperative gastric point-of-care ultrasound in nonelective surgical procedures in pediatric-aged patients.
   Ghimire A, Moharir A, Yamaguchi Y, Tram NK, et al · · 2024 · PMID 38313729 · DOI 10.4103/sja.sja_379_23