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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04964882

Enrollment

Registered

2021-07-16

Start date

2021-07-20

Completion date

2022-03-05

Last updated

2021-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Insufflation

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.

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.
Expiratory tidal volume	During anesthesia induction	Expiratory tidal volumes displayed on the monitor of the anesthesia machine are recorded.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026