Comparison of Peak Airway Pressure and Gastric Insufflation in Pressure-Controlled Ventilation or Volume-Controlled Ventilation With I-Gel in Pediatric Patient

NCT ID: NCT02259569

Last Updated: 2015-04-24

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

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-02-28

Brief Summary

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The purpose of this study is to compare peak airway pressure and gastric insufflation in Pressure-Controlled Ventilation or Volume-Controlled Ventilation with I-Gel in pediatric patient

Detailed Description

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Conditions

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Pediatric Urologic Surgeries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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PCV group

After insertion of I-gel, mechanical ventilation of the lungs was commenced. Mechanical ventilator was set to obtain a tidal volume of 8ml/kg in pressure-controlled mode.

Group Type EXPERIMENTAL

Pressure-controlled ventilation

Intervention Type OTHER

VCV group

After insertion of I-gel, mechanical ventilation of the lungs was commenced. Mechanical ventilator was set to obtain a tidal volume of 8ml/kg in volume-controlled mode.

Group Type ACTIVE_COMPARATOR

Volume-controlled ventilation

Intervention Type OTHER

Interventions

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Pressure-controlled ventilation

Intervention Type OTHER

Volume-controlled ventilation

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

① ASA I-II patients aged between 1 and 7 year undergoing elective urologic surgery.

Exclusion Criteria

* parent refusal

* clinically significant respiratory disease ③ congenital airway abnormalities, oropharyngeal or facial pathology ④ risk of aspiration
Minimum Eligible Age

6 Months

Maximum Eligible Age

7 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

Other Identifiers

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4-2014-0594

Identifier Type: -

Identifier Source: org_study_id

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