Manual Ventilation Versus Pressure Controlled Mechanical Ventilation in Children

Seoul National University

Status: Completed

Conditions: Ventilation

Treatments: Other: Pressure controlled mechanical ventilation; Other: manual ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT02751047

H1602-094-741

Details and patient eligibility

About

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.

Enrollment: 154 patients

Sex: All

Ages: 1 month to 5 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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154 participants in 2 patient groups, including a placebo group

Manual ventilation

Placebo Comparator group

Description:

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.

Treatment:

Other: manual ventilation

Pressure controlled mechanical ventilation

Active Comparator group

Description:

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.

Treatment:

Other: Pressure controlled mechanical ventilation