PEEP During Induction of Anesthesia in Small Children | NCT03540940

Studies
PEEP During Induction of Anesthesia in Small Children

NCT03540940

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Aug 19, 2019Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Pediatric Anesthesia

Interventions

PEEP
ZEEP

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

Aug 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 21, 2018Actual

Primary Completion Date

Aug 14, 2019Actual

Completion Date

Aug 14, 2019Actual

First Submitted Date

May 17, 2018

First Submission Date that Met QC Criteria

May 17, 2018

First Posted Date

May 30, 2018Actual

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

Aug 14, 2019

Last Update Posted Date

Aug 19, 2019Actual

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

Positive end-expiratory pressure (PEEP) applied during induction of anesthesia prevents atelectasis formation and increases the duration of nonhypoxic apnea in obese and nonobese patients. PEEP also prevents atelectasis formation in pediatric patients. Because pediatric patients arterial desaturation during induction of anesthesia develops rapidly, we studied the clinical benefit of PEEP applied during anesthesia induction.

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

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
zero positive end expiratory pressure	Experimental		Other: ZEEP
Positive end expiratory pressure	Experimental		Other: PEEP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PEEP	Other	7cmH2O positive end expiratory pressure	Positive end expiratory pressure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Duration of Apnea		from the start of apnea until SpO2 reached 95%, maximum 5 minutes.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

pediatric patients undergoing general anesthesia using endotracheal intubation

Exclusion Criteria:

previous history of lung disease
anticipated difficulty in airway management

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Month

Maximum Age

2 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hee-Soo Kim, Professor	Seoul National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hee-Soo Kim		Seoul	Soul-t'ukpyolsi	03080	South Korea
Seoul National University Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33259454	Derived	Kim EH, Lee JH, Jang YE, Ji SH, Cho SA, Kim JT, Kim HS. Effect of positive end-expiratory pressure during anaesthesia induction on non-hypoxic apnoea time in infants: A randomised controlled trial. Eur J Anaesthesiol. 2021 Oct 1;38(10):1012-1018. doi: 10.1097/EJA.0000000000001400.