The Comparison of the Effect of Pressure-controlled Ventilation and Volume-controlled Ventilation on the Gastric Insufflations in I-gel

General Anesthesia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02425618
• Other study ID #: 4-2015-0110
• Status: Completed
• Phase: N/A
• First received: April 9, 2015
• Last updated: June 3, 2015
• Start date: April 2015
• Est. completion date: May 2015

Study information

• Verified date: June 2015
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate whether the pressure controlled ventilation can reduce gastric insufflation compared to the volume controlled ventilation in patients who were mechanically ventilated with the i-gel.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• adult patients aged over 20 yrs who are scheduled for surgery under general anesthesia

Exclusion Criteria:

• upper gastrointestinal surgery

• surgery of long duration more than 4 hours

• anticipated difficult intubation

• body mass index more than 35 kg/m2

• pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• General Anesthesia

Intervention

Procedure:
• Volume-controlled ventilation
I-gel will be inserted into the patient's mouth. After confirmation of adequate ventilation with the i-gel, the patient's lungs will be mechanically ventilated using the volume-controlled mode with tidal volume 8 ml/kg during surgery.
• pressure-controlled ventilation
I-gel will be inserted into the patient's mouth. After confirmation of adequate ventilation with the i-gel, the patient's lungs will be mechanically ventilated using the pressure-controlled mode with tidal volume 8 ml/kg during surgery.

Device:
• I-gel

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	gastric antral area	The gastric antral area will be measured using ultrasonography.	Within 5 minutes after the end of surgery	Yes
Secondary	Peak airway pressure as indicated by mechanical ventilator		Within 5 minutes after the end of surgery	Yes