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NCT04645043 Clinical Trial

Ultrasound Guided Esophageal Pressure

Aspiration Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04645043
Other study ID # 2009-150-1160
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 19, 2020
Est. completion date March 18, 2021

Study information
Verified date April 2021
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date March 18, 2021
Est. primary completion date March 18, 2021
Accepts healthy volunteers No
Gender All
Age group N/A to 2 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Korea, Republic of Hee-Soo Kim Seoul Soul-t'ukpyolsi

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

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