Gastric Insufflation During Positive Pressure Ventilation

Not Applicable

• Conditions: Gastric Insufflation
• Interventions: Diagnostic Test: ultrasound examination of air insufflation in the upper esophageal region and stomach

• Registration Number: NCT04964882
• Lead Sponsor: SMG-SNU Boramae Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-31
• Status Verified: 2021-07
• Study First Submitted QC: 2021-07-06
• Last Update Submitted: 2021-07-06
• Study First Posted: 2021-07-16
• Last Update Posted: 2021-07-16
• Study Start: 2021-07-20
• Primary Completion: 2022-03-05
• Study Completion: 2022-03-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 78

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Presence of gastric insufflation in the epigastric region	During anesthesia induction	Under ultrasound, air signal is assessed in the epigastric region

Secondary Outcome Measures

Name	Time	Method
Expiratory tidal volume	During anesthesia induction	Expiratory tidal volumes displayed on the monitor of the anesthesia machine are recorded.
Cross-sectional area of the antral cross-sectional area	During anesthesia induction	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).
Presence of gastric insufflation in the upper esophageal region	During anesthesia induction	Under ultrasound, air signal is assessed in the upper esophageal region.