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NCT02751047 Clinical Trial

Manual Ventilation Versus Pressure Controlled Mechanical Ventilation in Children

Ventilation Clinical Trial

Official title:
Comparison Between Pressure Controlled Mechanical Ventilation and Manual Ventilation During Mask Ventilation for Induction of Anesthesia in Children

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02751047
Other study ID # H1602-094-741
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2016
Est. completion date January 2017

Study information
Verified date August 2018
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 154
Est. completion date January 2017
Est. primary completion date November 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Month to 5 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• manual ventilation
Facemask ventilation is performed by manual bagging with reservoir bag.
• Pressure controlled mechanical ventilation
Facemask ventilation is performed with mechanical ventilator by pressure controlled mode.

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of gastric insufflation During facemask ventilation (90 seconds)
Secondary The number of patients with adequate tidal volume Tidal volume of 6 - 10 ml/kg During facemask ventilation (90 seconds)
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