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NCT02466295 Clinical Trial

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 NCT02466295
Other study ID # 4-2015-0280
Secondary ID
Status Completed
Phase N/A
First received June 3, 2015
Last updated March 11, 2016
Start date June 2015
Est. completion date February 2016

Study information
Verified date March 2016
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 68
Est. completion date February 2016
Est. primary completion date January 2016
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

Intervention

Other:
• 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.

Locations
Country Name City State
Korea, Republic of Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine Seoul

Sponsors (1)
Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

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
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