Manual Ventilation Versus Pressure Controlled Mechanical Ventilation in Children

Sponsor

Seoul National University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02751047

Collaborator

(none)

154

Enrollment

Location

Arms

Actual Duration (Months)

19.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ventilation	Other: manual ventilation Other: Pressure controlled mechanical ventilation	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

154 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

May 1, 2016

Actual Primary Completion Date :

Nov 1, 2016

Actual Study Completion Date :

Jan 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 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.	Other: manual ventilation Facemask ventilation is performed by manual bagging with reservoir bag.
Active Comparator: 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.	Other: Pressure controlled mechanical ventilation Facemask ventilation is performed with mechanical ventilator by pressure controlled mode.

Arm

Intervention/Treatment

Placebo Comparator: 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.

Other: manual ventilation

Facemask ventilation is performed by manual bagging with reservoir bag.

Active Comparator: 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.

Other: Pressure controlled mechanical ventilation

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

Outcome Measures

Primary Outcome Measures

Incidence of gastric insufflation [During facemask ventilation (90 seconds)]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Month to 5 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of	110-744

Sponsors and Collaborators

Seoul National University Hospital

Investigators

Principal Investigator: Jin-Tae Kim, PhD, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jin-Tae Kim, Associated professor, Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT02751047

Other Study ID Numbers:

H1602-094-741

First Posted:

Apr 26, 2016

Last Update Posted:

Aug 22, 2018

Last Verified:

Aug 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Study Results

No Results Posted as of Aug 22, 2018