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Status unknownNCT04964882Updated Jul 16, 2021

Gastric Insufflation During Positive Pressure Ventilation

An interventional study of ultrasound examination of air insufflation in the upper esophageal region and stomach in Gastric Insufflation, sponsored by SMG-SNU Boramae Medical Center. Status unknown. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2021-07-16.

Sponsored by SMG-SNU Boramae Medical Center · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jul 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
78
Allocation
Non-randomized
Ages
20 Years and older
Sex
All
01

Study summary

Effect of peak inspiratory pressure on the gastric insufflation is evaluated using ultrasonography during face mask ventilation in obese adults. Effect of facial mask holding techniques on the gastric insufflation is also evaluated.

02

Conditions studied

  • Gastric Insufflation
03

In context

Lead sponsor

SMG-SNU Boramae Medical Center is the lead sponsor of 38 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with body mass index ≥ 30 kg/m2 who are scheduled for general anesthesia

Exclusion criteria

Exclusion Criteria:

  • Risk of delayed gastric emptying or gastroesophageal reflux (gastroesophageal reflux disease, achalasia, history of stomach surgery, gastrointestinal obstruction, uncontrolled DM)
  • Pregnancy
  • Known or predicted difficult airway
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
Single (Participant)
Enrollment
78 participants (estimated)

Study arms

  • Experimental
    C-E Mask ventilation under PIP 10 cmH2O

    Two-handed C-E technique is performed during face mask ventilation using a mechanical ventilator with a peak inspiratory pressure of 10 cmH2O.

    Diagnostic Test: ultrasound examination of air insufflation in the upper esophageal region and stomach

  • Experimental
    C-E Mask ventilation under PIP 15 cmH2O

    Two-handed C-E technique is performed during face mask ventilation using a mechanical ventilator with a peak inspiratory pressure of 15 cmH2O.

    Diagnostic Test: ultrasound examination of air insufflation in the upper esophageal region and stomach

  • Experimental
    C-E Mask ventilation under PIP 20 cmH2O

    Two-handed C-E technique is performed during face mask ventilation using a mechanical ventilator with a peak inspiratory pressure of 20 cmH2O.

    Diagnostic Test: ultrasound examination of air insufflation in the upper esophageal region and stomach

  • Experimental
    V-E Mask ventilation under PIP 10 cmH2O

    Two-handed V-E technique is performed during face mask ventilation using a mechanical ventilator with a peak inspiratory pressure of 10 cmH2O.

    Diagnostic Test: ultrasound examination of air insufflation in the upper esophageal region and stomach

  • Experimental
    V-E Mask ventilation under PIP 15 cmH2O

    Two-handed V-E technique is performed during face mask ventilation using a mechanical ventilator with a peak inspiratory pressure of 15 cmH2O.

    Diagnostic Test: ultrasound examination of air insufflation in the upper esophageal region and stomach

  • Experimental
    V-E Mask ventilation under PIP 20 cmH2O

    Two-handed V-E technique is performed during face mask ventilation using a mechanical ventilator with a peak inspiratory pressure of 20 cmH2O.

    Diagnostic Test: ultrasound examination of air insufflation in the upper esophageal region and stomach

Interventions

  • Diagnostic testultrasound examination of air insufflation in the upper esophageal region and stomach

    Presence of air insufflation is assessed using ultrasound in the upper esophageal region and stomach during face mask ventilation

06

What researchers measure

Primary outcomes

  1. Presence of gastric insufflation in the epigastric region

    Under ultrasound, air signal is assessed in the epigastric region

    Time frame: During anesthesia induction

Secondary outcomes

  1. Cross-sectional area of the antral cross-sectional area

    During ultrasound examination, anterior-posterior diameter and cranio-caudal diameter of the antrum are measured. Cross-sectional area of the gastric antrum is calculated as follows; (AP × CC × π)/4 (AP=antero-posterior diameter and CC=cranio-caudal diameter).

    Time frame: During anesthesia induction

  2. Presence of gastric insufflation in the upper esophageal region

    Under ultrasound, air signal is assessed in the upper esophageal region.

    Time frame: During anesthesia induction

  3. Expiratory tidal volume

    Expiratory tidal volumes displayed on the monitor of the anesthesia machine are recorded.

    Time frame: During anesthesia induction

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04964882
Lead sponsor
SMG-SNU Boramae Medical Center
Responsible party
Jin-Young Hwang (Associate professor, SMG-SNU Boramae Medical Center) — Principal investigator
First posted
Jul 16, 2021
Start date
Jul 20, 2021 (estimated)
Primary completion
Mar 5, 2022 (estimated)
Completion
Mar 5, 2022 (estimated)
Last update
Jul 16, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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