Manual Ventilation Versus Pressure Controlled Mechanical Ventilation in Children
Comparison Between Pressure Controlled Mechanical Ventilation and Manual Ventilation During Mask Ventilation for Induction of Anesthesia in Children
1 other identifier
interventional
154
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 22, 2016
CompletedFirst Posted
Study publicly available on registry
April 26, 2016
CompletedStudy Start
First participant enrolled
May 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedAugust 22, 2018
August 1, 2018
6 months
April 22, 2016
August 20, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of gastric insufflation
During facemask ventilation (90 seconds)
Secondary Outcomes (1)
The number of patients with adequate tidal volume
During facemask ventilation (90 seconds)
Study Arms (2)
Manual ventilation
PLACEBO COMPARATORDuring 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.
Pressure controlled mechanical ventilation
ACTIVE COMPARATORDuring 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.
Interventions
Facemask ventilation is performed by manual bagging with reservoir bag.
Facemask ventilation is performed with mechanical ventilator by pressure controlled mode.
Eligibility Criteria
You may qualify if:
- Children with American Society of Anesthesiologist (ASA) physical status 1, 2
- Children with normal body mass index
You may not qualify if:
- Difficult airway management
- pulmonary disease
- upper respiratory infection
- risk of pulmonary aspiration
- intestinal obstruction or abdominal distension
- stroke history or moyamoya disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, 110-744, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jin-Tae Kim, PhD
Seoul National University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associated professor
Study Record Dates
First Submitted
April 22, 2016
First Posted
April 26, 2016
Study Start
May 1, 2016
Primary Completion
November 1, 2016
Study Completion
January 1, 2017
Last Updated
August 22, 2018
Record last verified: 2018-08