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

NCT ID: NCT02466295

Last Updated: 2016-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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General Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Volume-controlled ventilation

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

Group Type EXPERIMENTAL

Volume-controlled ventilation

Intervention Type OTHER

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

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

Group Type EXPERIMENTAL

Pressure-controlled ventilation

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2015-0280

Identifier Type: -

Identifier Source: org_study_id

NCT02425618

Identifier Type: -

Identifier Source: nct_alias

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