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Ultrasound Guided Esophageal Pressure

Sponsor
Seoul National University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04645043
Collaborator
(none)
50
Enrollment
1
Location
1
Arm
3.9
Actual Duration (Months)
12.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: US_Eso
 N/A

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
The Effect of Real Time Ultrasound Guided Esophageal Pressure on Preventing Gastric Insufflation in Infants and Children: an Exploratory Study
Actual Study Start Date :
Nov 19, 2020
Actual Primary Completion Date :
Mar 18, 2021
Actual Study Completion Date :
Mar 18, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. the incidence of gastric air insufflation [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.

Secondary Outcome Measures

  1. Gastric insufflation detected by esophageal ultrasound [during face mask ventilation, maximum 3 minutes.]

  2. ventilatory parameters [during face mask ventilation, maximum 3 minutes.]

    tidal volume, end tidal carbon dioxide, minimal oxygen saturation

  3. POGO (percentage of glottic opening) score [during endotracheal intubation, maximum 3 minutes]

    POGO (percentage of glottic opening, 0-100) score with videolaryngoscope

  4. relative position of esophagus with trachea [during anesthetic induction, maximal 3 minutes]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 2 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hee-Soo Kim Seoul Soul-t'ukpyolsi Korea, Republic of 03080

Sponsors and Collaborators

  • Seoul National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hee-Soo Kim, professor, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT04645043
Other Study ID Numbers:
  • 2009-150-1160
First Posted:
Nov 25, 2020
Last Update Posted:
Apr 27, 2021
Last Verified:
Apr 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 27, 2021