Gastric Insufflation During Positive Pressure Ventilation

Gastric Insufflation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04964882
• Other study ID #: 31-2021
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 20, 2021
• Est. completion date: March 5, 2022

Study information

• Verified date: July 2021
• Source: SMG-SNU Boramae Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 78
• Est. completion date: March 5, 2022
• Est. primary completion date: March 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastric Insufflation

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
SMG-SNU Boramae Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of gastric insufflation in the epigastric region	Under ultrasound, air signal is assessed in the epigastric region	During anesthesia induction
Secondary	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 × p)/4 (AP=antero-posterior diameter and CC=cranio-caudal diameter).	During anesthesia induction
Secondary	Presence of gastric insufflation in the upper esophageal region	Under ultrasound, air signal is assessed in the upper esophageal region.	During anesthesia induction
Secondary	Expiratory tidal volume	Expiratory tidal volumes displayed on the monitor of the anesthesia machine are recorded.	During anesthesia induction