Determination of Optimal Mask Ventilation Mode in Pediatr... | NCT03881033

Studies
Determination of Optimal Mask Ventilation Mode in Pediatrics Using Real-time Ultrasonography

NCT03881033

Sponsor

Ajou University School of Medicine

Status

Unknown status

Last Update Posted

Mar 19, 2019Actual

Enrollment

70Estimated

Phase

Not Applicable

Conditions

Ventilator Lung
Ultrasound

Interventions

Peep 5cmH2O
Peak inspiratory pressure

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2019Estimated

Primary Completion Date

Sep 30, 2019Estimated

Completion Date

Nov 30, 2019Estimated

First Submitted Date

Mar 12, 2019

First Submission Date that Met QC Criteria

Mar 18, 2019

First Posted Date

Mar 19, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 18, 2019

Last Update Posted Date

Mar 19, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jiyoung Yoo, assistant professor, Ajou University School of MedicinePrincipal Investigator

Lead Sponsor

Ajou University School of MedicineOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The peak inspiratory pressure during face mask ventilation for general anesthesia is closely correlated with gastric insufflation. High pressure increases the amount of air in stomach and low pressure could decrease the tidal volume, therefore ideal pressure means the pressure guarantee adequate ventilation with minimal gastric insufflation.

The aim of this study is finding the proper pressure and mode of face mask ventilation in pediatric patients.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
P12	Placebo Comparator		Other: Peak inspiratory pressure
P7+5	Active Comparator		Other: Peep 5cmH2O

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Peep 5cmH2O	Other	Face mask ventilation with peak inspiratory pressure according to the group P7+5 means face mask ventilation with peak inspiratory pressure 7cmH2O plus PEEP 5 cmH2O.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The degree of atelectasis	After intubation, confirming endotracheal intubation, the ventilator is connected and turned on.	1min after ventilator-on

Secondary Outcomes

Measure	Description	Time Frame
The incidence of gastric insufflation		During face mask ventilation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The ASA class I,II and 1-5 years pediatric patients need general anesthesia

Exclusion Criteria:

Oropharyngeal or facial pathology accompanied
Obese (BMI > 30 kg/m2)
GI tract obstruction

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

5 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided