Gastric Insufflation During Positive Pressure Ventilation

NCT04964882 | Unknown

• 1 other identifier: 31-2021
• Study Type: interventional
• Target: 78
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gastric Insufflation

Outcome Measures

Primary Outcomes (1)

• Presence of gastric insufflation in the epigastric region

  Under ultrasound, air signal is assessed in the epigastric region

  During anesthesia induction

Secondary Outcomes (3)

• Cross-sectional area of the antral cross-sectional area

  During anesthesia induction

• Presence of gastric insufflation in the upper esophageal region

  During anesthesia induction

• Expiratory tidal volume

  During anesthesia induction

Study Arms (6)

C-E Mask ventilation under PIP 10 cmH2O

EXPERIMENTAL

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

C-E Mask ventilation under PIP 15 cmH2O

EXPERIMENTAL

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

C-E Mask ventilation under PIP 20 cmH2O

EXPERIMENTAL

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

V-E Mask ventilation under PIP 10 cmH2O

EXPERIMENTAL

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

V-E Mask ventilation under PIP 15 cmH2O

EXPERIMENTAL

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

V-E Mask ventilation under PIP 20 cmH2O

EXPERIMENTAL

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

Interventions

ultrasound examination of air insufflation in the upper esophageal region and stomach 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 10 cmH2O; C-E Mask ventilation under PIP 15 cmH2O; C-E Mask ventilation under PIP 20 cmH2O; V-E Mask ventilation under PIP 10 cmH2O; V-E Mask ventilation under PIP 15 cmH2O; V-E Mask ventilation under PIP 20 cmH2O

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with body mass index ≥ 30 kg/m2 who are scheduled for general anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• SMG-SNU Boramae Medical Center: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: July 16, 2021
• Study Start: July 20, 2021
• Primary Completion: March 5, 2022
• Study Completion: March 5, 2022
• Last Updated: July 16, 2021

Record last verified: 2021-07