Determination of Optimal Mask Ventilation Mode in Pediatrics Using Real-time Ultrasonography

NCT ID: NCT03881033

Last Updated: 2019-03-19

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2019-11-30

Brief Summary

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The peak inspiratory pressure during face mask ventilation for general anesthesia is closely correlated with gastric insufflation. High pressure increases the amount of air in stomach and low pressure could decrease the tidal volume, therefore ideal pressure means the pressure guarantee adequate ventilation with minimal gastric insufflation.

The aim of this study is finding the proper pressure and mode of face mask ventilation in pediatric patients.

Detailed Description

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Conditions

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Ventilator Lung Ultrasound

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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P12

Group Type PLACEBO_COMPARATOR

Peak inspiratory pressure

Intervention Type OTHER

Face mask ventilation with peak inspiratory pressure according to the group P12 means face mask ventilation with peak inspiratory pressure 12cmH2O without PEEP.

P7+5

Group Type ACTIVE_COMPARATOR

Peep 5cmH2O

Intervention Type OTHER

Face mask ventilation with peak inspiratory pressure according to the group P7+5 means face mask ventilation with peak inspiratory pressure 7cmH2O plus PEEP 5 cmH2O.

Interventions

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Peep 5cmH2O

Face mask ventilation with peak inspiratory pressure according to the group P7+5 means face mask ventilation with peak inspiratory pressure 7cmH2O plus PEEP 5 cmH2O.

Intervention Type OTHER

Peak inspiratory pressure

Face mask ventilation with peak inspiratory pressure according to the group P12 means face mask ventilation with peak inspiratory pressure 12cmH2O without PEEP.

Intervention Type OTHER

Other Intervention Names

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Peak inspiratory pressure

Eligibility Criteria

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Inclusion Criteria

* The ASA class I,II and 1-5 years pediatric patients need general anesthesia

Exclusion Criteria

* Oropharyngeal or facial pathology accompanied
* Obese (BMI \> 30 kg/m2)
* GI tract obstruction
Minimum Eligible Age

1 Year

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ajou University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Jiyoung Yoo

assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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AJIRB-MED-OBS-18-192

Identifier Type: -

Identifier Source: org_study_id

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