Manual Ventilation Versus Pressure Controlled Mechanical Ventilation in Children

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

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2017-01-31

Brief Summary

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The investigator will compare the feasibility of manual ventilation and pressure-controlled mechanical ventilation during facemask ventilation in children. The hypothesis is that the incidence of gastric insufflation would be lower during pressure-controlled mechanical ventilation when compared to manual ventilation.

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Detailed Description

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Conditions

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Ventilation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Manual ventilation

During anesthetic induction, facemask ventilation is performed by manual bagging, after setting adjustable pressure limiting (APL) valve at 13 cmH2O. During mask ventilation, gastric ultrasonography is continuously performed to detect gastric insufflation.

Group Type PLACEBO_COMPARATOR

manual ventilation

Intervention Type OTHER

Facemask ventilation is performed by manual bagging with reservoir bag.

Pressure controlled mechanical ventilation

During anesthetic induction, facemask ventilation is performed with mechanical ventilator by pressure controlled mode, with inspiratory pressure of 13 cmH2O. During mask ventilation, gastric ultrasonography is continuously performed to detect gastric insufflation.

Group Type ACTIVE_COMPARATOR

Pressure controlled mechanical ventilation

Intervention Type OTHER

Facemask ventilation is performed with mechanical ventilator by pressure controlled mode.

Interventions

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manual ventilation

Facemask ventilation is performed by manual bagging with reservoir bag.

Intervention Type OTHER

Pressure controlled mechanical ventilation

Facemask ventilation is performed with mechanical ventilator by pressure controlled mode.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Children with American Society of Anesthesiologist (ASA) physical status 1, 2
* Children with normal body mass index

Exclusion Criteria

* Difficult airway management
* pulmonary disease
* upper respiratory infection
* risk of pulmonary aspiration
* intestinal obstruction or abdominal distension
* stroke history or moyamoya disease

Minimum Eligible Age

1 Month

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes