Gastric Insufflation During Positive Pressure Ventilation

NCT ID: NCT04964882

Last Updated: 2021-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-20

Study Completion Date

2022-03-05

Brief Summary

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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

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Conditions

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Gastric Insufflation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type DIAGNOSTIC_TEST

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

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.

Group Type EXPERIMENTAL

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

Intervention Type DIAGNOSTIC_TEST

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

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.

Group Type EXPERIMENTAL

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

Intervention Type DIAGNOSTIC_TEST

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

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.

Group Type EXPERIMENTAL

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

Intervention Type DIAGNOSTIC_TEST

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

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.

Group Type EXPERIMENTAL

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

Intervention Type DIAGNOSTIC_TEST

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

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.

Group Type EXPERIMENTAL

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

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SMG-SNU Boramae Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jin-Young Hwang

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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31-2021

Identifier Type: -

Identifier Source: org_study_id

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