Manual Ventilation Versus Pressure Controlled Mechanical Ventilation in Children

Not Applicable

Completed

• Conditions: Ventilation
• Interventions: Other: manual ventilation; Other: Pressure controlled mechanical ventilation

• Registration Number: NCT02751047
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-22
• Study First Submitted QC: 2016-04-22
• Study First Posted: 2016-04-26
• Study Start: 2016-05
• Primary Completion: 2016-11
• Study Completion: 2017-01
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-20
• Last Update Posted: 2018-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Manual ventilation	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.
Pressure controlled mechanical ventilation	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.

Primary Outcome Measures

Name	Time	Method
Incidence of gastric insufflation	During facemask ventilation (90 seconds)

Secondary Outcome Measures

Name	Time	Method
The number of patients with adequate tidal volume	During facemask ventilation (90 seconds)	Tidal volume of 6 - 10 ml/kg

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of