Manual Ventilation Versus Pressure Controlled Mechanical Ventilation in Children

August 20, 2018 updated by: Jin-Tae Kim, Seoul National University Hospital

Comparison Between Pressure Controlled Mechanical Ventilation and Manual Ventilation During Mask Ventilation for Induction of Anesthesia in Children

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

154

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 5 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 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.
Other: manual ventilation
Facemask ventilation is performed by manual bagging with reservoir bag.
Active Comparator: 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.
Other: Pressure controlled mechanical ventilation
Facemask ventilation is performed with mechanical ventilator by pressure controlled mode.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of gastric insufflation
Time Frame: During facemask ventilation (90 seconds)
During facemask ventilation (90 seconds)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of patients with adequate tidal volume
Time Frame: During facemask ventilation (90 seconds)
Tidal volume of 6 - 10 ml/kg
During facemask ventilation (90 seconds)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

April 22, 2016

First Submitted That Met QC Criteria

April 22, 2016

First Posted (Estimate)

April 26, 2016

Study Record Updates

Last Update Posted (Actual)

August 22, 2018

Last Update Submitted That Met QC Criteria

August 20, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • H1602-094-741

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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