NCT03155776

Brief Summary

Aspiration of gastric contents can be a serious anesthetic related complication. Gastric antral sonography prior to anesthesia may have a role in identifying pediatric patients at risk of aspiration. The investigator examined the relationship between sonographic antral area and endoscopically suctioned gastric volumes infants.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 16, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

June 15, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

February 4, 2021

Status Verified

February 1, 2021

Enrollment Period

1.8 years

First QC Date

May 15, 2017

Last Update Submit

February 3, 2021

Conditions

Fasting

Outcome Measures

Primary Outcomes (1)

  • gastric antral cross sectional area

    ultrasound assessment of gastric antral cross sectional area

    immediate after anesthetic induction within 1 minutes.

Study Arms (1)

GUS_infants

Infants patient undergoing general anesthesia for abdominal surgery

Diagnostic Test: GUS

Interventions

GUSDIAGNOSTIC_TEST

gastric volume estimation using gastric ultrasound was performed immediately after anesthetic induction, and after aspirating the residual gastric contents using nasogastric tube

GUS_infants

Eligibility Criteria

AgeUp to 1 Year
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Infants undergoing general anesthesia for abdominal surgery

You may qualify if:

  • Infants undergoing general anesthesia with endotracheal intubation were included in this study

You may not qualify if:

  • a recent (≤1 month) history of oesophageal or gastric surgery, gastrostomy or ileostomy, diaphragmatic hernia, emergent surgery, or a prolonged duration (\>5 min) between completion of US assessment and suctioning of gastric contents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jin-Tae Kim

Seoul, South Korea

Location

Related Publications (1)

  • Kim EH, Yoon HC, Lee JH, Kim HS, Jang YE, Ji SH, Cho SA, Kim JT. Prediction of gastric fluid volume by ultrasonography in infants undergoing general anaesthesia. Br J Anaesth. 2021 Aug;127(2):275-280. doi: 10.1016/j.bja.2021.03.039. Epub 2021 May 25.

    PMID: 34045064DERIVED

MeSH Terms

Conditions

Fasting

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 15, 2017

First Posted

May 16, 2017

Study Start

June 15, 2017

Primary Completion

April 1, 2019

Study Completion

April 1, 2019

Last Updated

February 4, 2021

Record last verified: 2021-02

Locations

KR(1)