NCT02466295

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 3, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 9, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

March 14, 2016

Status Verified

March 1, 2016

Enrollment Period

7 months

First QC Date

June 3, 2015

Last Update Submit

March 11, 2016

Conditions

General Anesthesia

Outcome Measures

Primary Outcomes (1)

  • gastric antral area

    The gastric antral area will be measured using ultrasonography.

    Within 5 minutes after the end of surgery

Study Arms (2)

Volume-controlled ventilation

EXPERIMENTAL

The patient's lungs will be mechanically ventilated using the volume-controlled ventilation with tidal volume 8 ml/kg.

Other: Volume-controlled ventilation

Pressure-controlled ventilation

EXPERIMENTAL

The patient's lungs will be mechanically ventilated using the pressure-controlled ventilation with tidal volume 8 ml/kg.

Other: Pressure-controlled ventilation

Interventions

Volume-controlled ventilationOTHER

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.

Volume-controlled ventilation
Pressure-controlled ventilationOTHER

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.

Pressure-controlled ventilation

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • upper gastrointestinal surgery,
  • surgery of long duration more than 4 hours,
  • anticipated difficult intubation,
  • body mass index more than 35 kg/m2,
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Seoul, Seoul, 120-752, South Korea

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2015

First Posted

June 9, 2015

Study Start

June 1, 2015

Primary Completion

January 1, 2016

Study Completion

February 1, 2016

Last Updated

March 14, 2016

Record last verified: 2016-03

Locations

KR(1)