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Manual Ventilation Versus Pressure Controlled Mechanical Ventilation in Children

Seoul National University logo

Seoul National University

Status

Completed

Conditions

Ventilation

Treatments

Other: manual ventilation
Other: Pressure controlled mechanical 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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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