Gastric Insufflation During Positive Pressure Ventilation

Effect of the Peak Inspiratory Pressure and Facial Mask Holding Techniques on the Gastric Insufflation During Positive Pressure Ventilation With Facemask in Obese Adults

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Gastric Insufflation
• Intervention / Treatment: Diagnostic test: ultrasound examination of air insufflation in the upper esophageal region and stomach

• Study Type: Interventional
• Enrollment (Anticipated): 78
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Presence of air insufflation is assessed using ultrasound in the upper esophageal region and stomach during face mask ventilation
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; Presence of air insufflation is assessed using ultrasound in the upper esophageal region and stomach during face mask ventilation
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; Presence of air insufflation is assessed using ultrasound in the upper esophageal region and stomach during face mask ventilation
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; Presence of air insufflation is assessed using ultrasound in the upper esophageal region and stomach during face mask ventilation
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; Presence of air insufflation is assessed using ultrasound in the upper esophageal region and stomach during face mask ventilation
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; Presence of air insufflation is assessed using ultrasound in the upper esophageal region and stomach during face mask ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of gastric insufflation in the epigastric region	Under ultrasound, air signal is assessed in the epigastric region	During anesthesia induction

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	During anesthesia induction
Presence of gastric insufflation in the upper esophageal region	Under ultrasound, air signal is assessed in the upper esophageal region.	During anesthesia induction
Expiratory tidal volume	Expiratory tidal volumes displayed on the monitor of the anesthesia machine are recorded.	During anesthesia induction

Collaborators and Investigators

• Sponsor: SMG-SNU Boramae Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): July 20, 2021
• Primary Completion (Anticipated): March 5, 2022
• Study Completion (Anticipated): March 5, 2022

Study Registration Dates

• First Submitted: March 31, 2021
• First Submitted That Met QC Criteria: July 6, 2021
• First Posted (Actual): July 16, 2021

Study Record Updates

• Last Update Posted (Actual): July 16, 2021
• Last Update Submitted That Met QC Criteria: July 6, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 31-2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No