Efficacy Evaluation of Positive End-expiratory Pressure i... | NCT05275283

Studies
Efficacy Evaluation of Positive End-expiratory Pressure in Children Undergoing Mechanical Ventilation Using Supraglottic Airway Device

NCT05275283

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Mar 11, 2022Actual

Enrollment

94Estimated

Phase

Not Applicable

Conditions

Positive End Expiratory Pressure

Interventions

PEEP

Countries

South Korea

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 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 3, 2022Actual

Primary Completion Date

Dec 30, 2023Estimated

Completion Date

Dec 30, 2023Estimated

First Submitted Date

Nov 29, 2021

First Submission Date that Met QC Criteria

Mar 1, 2022

First Posted Date

Mar 11, 2022Actual

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 1, 2022

Last Update Posted Date

Mar 11, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hee-Soo Kim, Professor, Seoul National University HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

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 aim of this study is to determine whether application of positive end-expiratory pressure (PEEP) improves respiratory data including respiratory compliance in children who receive positive pressure ventilation using supraglottic airway device (SAD).

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

94Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control group	No Intervention	Applying tidal volume 7 ml/kg without PEEP
PEEP group	Experimental	Applying tidal volume 7 ml/kg with 6 cmH2O of PEEP	Other: PEEP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PEEP	Other	6 cmH2O of PEEP	PEEP group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Respiratory system compliance	total lung and chest wall compliance, ml/cmH2O	at the end of surgery, about 2 hours after starting of mechanical ventilation

Secondary Outcomes

Measure	Description	Time Frame
Respiratory system compliance	total lung and chest wall compliance, ml/cmH2O	10 minutes, 30 minutes, 60 minutes after starting of mechanical ventilation
oropharyngeal leak pressure	cmH2O

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pediatric patients under 6 years of age who are scheduled simple operation under general anesthesia
SAD was used for mechanical ventilation

Exclusion Criteria:

Abdominal distension, risk of pulmonary aspiration
Bronchopulmonary dysplasia/respiratory distress syndrome
Pneumothorax
Airway surgery
Thoracic surgery or laparotomy
Surgery under prone position

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

6 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hee-Soo Kim, MD, PhD	Contact	02-2072-3659	82	dami0605@snu.ac.kr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hee-Soo Kim	Recruiting	Seoul		03080	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided