NCT04645043

Brief Summary

The investigator aimed to evaluate the effect of ultrasound guided esophageal pressure on the incidence of gastric insufflation during anesthetic induction in infants and small children undergoing general anesthesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

November 19, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 25, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2021

Completed
Last Updated

April 27, 2021

Status Verified

April 1, 2021

Enrollment Period

4 months

First QC Date

November 19, 2020

Last Update Submit

April 23, 2021

Conditions

AspirationInfant Conditions

Outcome Measures

Primary Outcomes (1)

  • the incidence of gastric air insufflation

    the incidence of gastric air insufflation during induction of anesthesia when applying real time ultrasound guided esophageal pressure.

    during face mask ventilation, maximum 3 minutes.

Secondary Outcomes (4)

  • Gastric insufflation detected by esophageal ultrasound

    during face mask ventilation, maximum 3 minutes.

  • ventilatory parameters

    during face mask ventilation, maximum 3 minutes.

  • POGO (percentage of glottic opening) score

    during endotracheal intubation, maximum 3 minutes

  • relative position of esophagus with trachea

    during anesthetic induction, maximal 3 minutes

Study Arms (1)

US_Eso

EXPERIMENTAL

US application on the participant

Other: US_Eso

Interventions

US_EsoOTHER

After applying ultrasound guided esophageal pressure, the peak inspiratory pressure increased from 10cmH2O to 24cmH2O (increased by 2 cmH2O) during mask ventilation.

US_Eso

Eligibility Criteria

AgeUp to 2 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • patients undergoing general anesthesia with endotracheal intubation

You may not qualify if:

  • patients with hypertrophic pyloric stenosis
  • patients with delayed gastric emptying
  • patients with esophageal stenosis
  • patients with at risk of gastric aspiration
  • patients with ileus, hepatomegaly, ascites (cannot visualize gastric antrum with ultrasound)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hee-Soo Kim

Seoul, Soul-t'ukpyolsi, 03080, South Korea

Location

Related Publications (1)

  • Kim EH, Cho SA, Kang P, Song IS, Ji SH, Jang YE, Lee JH, Kim JT, Kim HS. Ultrasound-guided esophageal compression during mask ventilation in small children: a prospective observational study. BMC Anesthesiol. 2022 Aug 15;22(1):257. doi: 10.1186/s12871-022-01803-5.

    PMID: 35971064DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

November 19, 2020

First Posted

November 25, 2020

Study Start

November 19, 2020

Primary Completion

March 18, 2021

Study Completion

March 18, 2021

Last Updated

April 27, 2021

Record last verified: 2021-04

Locations

KR(1)