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Completed

NCT Number: NCT04645043

Ultrasound Guided Esophageal Pressure

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.

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Key information

Conditions

Aspiration Infant Conditions

Age range

Up to 2 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hee-Soo Kim

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

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

US_Eso

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Gastric insufflation detected by esophageal ultrasound

    Time frame: during face mask ventilation, maximum 3 minutes.

  2. ventilatory parameters

    Time frame: during face mask ventilation, maximum 3 minutes.

    tidal volume, end tidal carbon dioxide, minimal oxygen saturation

  3. POGO (percentage of glottic opening) score

    Time frame: during endotracheal intubation, maximum 3 minutes

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

  4. relative position of esophagus with trachea

    Time frame: during anesthetic induction, maximal 3 minutes

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 25, 2020
Registry last updated
Apr 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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