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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02751047
Enrollment
154
Registered
2016-04-26
Start date
2016-05-31
Completion date
2017-01-31
Last updated
2018-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventilation

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.

Interventions

Facemask ventilation is performed by manual bagging with reservoir bag.

OTHERPressure controlled mechanical ventilation

Facemask ventilation is performed with mechanical ventilator by pressure controlled mode.

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
1 Months to 5 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Incidence of gastric insufflationDuring facemask ventilation (90 seconds)

Secondary

MeasureTime frameDescription
The number of patients with adequate tidal volumeDuring facemask ventilation (90 seconds)Tidal volume of 6 - 10 ml/kg

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026