Gastric Insufflation During Positive Pressure Ventilation

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Seoul National University

Status

Unknown

Conditions

Gastric Insufflation

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT04964882
31-2021

Details and patient eligibility

About

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.

Enrollment

78 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

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

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

Single Blind

78 participants in 6 patient groups

C-E Mask ventilation under PIP 10 cmH2O
Experimental group
Description:
Two-handed C-E technique is performed during face mask ventilation using a mechanical ventilator with a peak inspiratory pressure of 10 cmH2O.
Treatment:
Diagnostic Test: ultrasound examination of air insufflation in the upper esophageal region and stomach
C-E Mask ventilation under PIP 15 cmH2O
Experimental group
Description:
Two-handed C-E technique is performed during face mask ventilation using a mechanical ventilator with a peak inspiratory pressure of 15 cmH2O.
Treatment:
Diagnostic Test: ultrasound examination of air insufflation in the upper esophageal region and stomach
C-E Mask ventilation under PIP 20 cmH2O
Experimental group
Description:
Two-handed C-E technique is performed during face mask ventilation using a mechanical ventilator with a peak inspiratory pressure of 20 cmH2O.
Treatment:
Diagnostic Test: ultrasound examination of air insufflation in the upper esophageal region and stomach
V-E Mask ventilation under PIP 10 cmH2O
Experimental group
Description:
Two-handed V-E technique is performed during face mask ventilation using a mechanical ventilator with a peak inspiratory pressure of 10 cmH2O.
Treatment:
Diagnostic Test: ultrasound examination of air insufflation in the upper esophageal region and stomach
V-E Mask ventilation under PIP 15 cmH2O
Experimental group
Description:
Two-handed V-E technique is performed during face mask ventilation using a mechanical ventilator with a peak inspiratory pressure of 15 cmH2O.
Treatment:
Diagnostic Test: ultrasound examination of air insufflation in the upper esophageal region and stomach
V-E Mask ventilation under PIP 20 cmH2O
Experimental group
Description:
Two-handed V-E technique is performed during face mask ventilation using a mechanical ventilator with a peak inspiratory pressure of 20 cmH2O.
Treatment:
Diagnostic Test: ultrasound examination of air insufflation in the upper esophageal region and stomach

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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