Ultrasound Guided Esophageal Pressure

April 23, 2021 updated by: Hee-Soo Kim, Seoul National University Hospital

The Effect of Real Time Ultrasound Guided Esophageal Pressure on Preventing Gastric Insufflation in Infants and Children: an Exploratory Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

effect of ultrasound guided esophageal pressure on the incidence of gastric insufflation in children

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Soul-t'ukpyolsi
      • Seoul, Soul-t'ukpyolsi, Korea, Republic of, 03080
        • Hee-Soo Kim

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients undergoing general anesthesia with endotracheal intubation

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: US_Eso
US application on the participant
Other: US_Eso
After applying ultrasound guided esophageal pressure, the peak inspiratory pressure increased from 10cmH2O to 24cmH2O (increased by 2 cmH2O) during mask ventilation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the incidence of gastric air insufflation
Time Frame: during face mask ventilation, maximum 3 minutes.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastric insufflation detected by esophageal ultrasound
Time Frame: during face mask ventilation, maximum 3 minutes.
during face mask ventilation, maximum 3 minutes.
ventilatory parameters
Time Frame: during face mask ventilation, maximum 3 minutes.
tidal volume, end tidal carbon dioxide, minimal oxygen saturation
during face mask ventilation, maximum 3 minutes.
POGO (percentage of glottic opening) score
Time Frame: during endotracheal intubation, maximum 3 minutes
POGO (percentage of glottic opening, 0-100) score with videolaryngoscope
during endotracheal intubation, maximum 3 minutes
relative position of esophagus with trachea
Time Frame: during anesthetic induction, maximal 3 minutes
during anesthetic induction, maximal 3 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 19, 2020

Primary Completion (Actual)

March 18, 2021

Study Completion (Actual)

March 18, 2021

Study Registration Dates

First Submitted

November 19, 2020

First Submitted That Met QC Criteria

November 19, 2020

First Posted (Actual)

November 25, 2020

Study Record Updates

Last Update Posted (Actual)

April 27, 2021

Last Update Submitted That Met QC Criteria

April 23, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 2009-150-1160

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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