End-Expiratory Lung Volume in Children Awakening From Pro... | NCT05821114

Studies
End-Expiratory Lung Volume in Children Awakening From Propofol Anesthesia

NCT05821114

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Apr 20, 2023Actual

Enrollment

52Estimated

Phase

Not Applicable

Conditions

Atelectasis, Postoperative Pulmonary

Interventions

Head elevation_H
Supine_H
Head elevation_L
Supine_L

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

Apr 2023

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

Apr 7, 2023Actual

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Apr 7, 2023

First Submission Date that Met QC Criteria

Apr 7, 2023

First Posted Date

Apr 20, 2023Actual

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

Apr 7, 2023

Last Update Posted Date

Apr 20, 2023Actual

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 goal of this pilot randomized clinical trial is to test the effects of high flow nasal oxygen and head elevation during awakening from propofol anesthesia in pediatric patients undergoing airway surgery.

The main question[s] it aims to answer are:

High flow oxygen can decrease the occurence of atelectasis during awakening from propofol anesthesia in pediatric patients?
Head elevation can decrease the occurence of atelectasis during awakening from propofol anesthesia in pediatric patients?

Researchers will compare high flow oxygen vs low flow oxygen group to see if the use of high flow oxygen decrease the occurence of atelectasis during awakening from propofol anesthesia.

And in each group, the patients will be assigned to supine position vs head elevation position to compare the effects of head elevation during awakening from propofol anesthesia.

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

52Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
high flow oxygen	Experimental	Oxygen supply (2L/kg/min.) during awakening from propofol anesthesia	Other: Head elevation_H Other: Supine_H
Low flow oxygen	Active Comparator	Oxygen supply (0.3L/kg/min.) during awakening from propofol anesthesia	Other: Head elevation_L Other: Supine_L

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Head elevation_H	Other	High flow_Head-elevation	high flow oxygen

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in Electric Impedance Tomography parameter		from induction of anesthesia to end of operation, about 3 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pediatric patients undergoing airway surgery with high flow nasal oxygen

Exclusion Criteria:

Loss of spontaneous ventilation during surgery
less than 1 months
cyanotic patients

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Month

Maximum Age

7 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

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

Condition Browse Module

MeSH Terms

ID	Term
D001261	Pulmonary Atelectasis

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided