Ultrasound Assessed Gastric Volume in the Fasted Pediatri... | NCT05185336

Studies
Ultrasound Assessed Gastric Volume in the Fasted Pediatric Cerebral Palsy Patients

NCT05185336

Sponsor

Seoul National University Bundang Hospital

Status

Unknown status

Last Update Posted

Jan 11, 2022Actual

Enrollment

38Estimated

Phase

Not provided

Conditions

Cerebral Palsy

Interventions

ultrasound assessment

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

Dec 2021

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

Feb 10, 2022Estimated

Primary Completion Date

Feb 10, 2022Estimated

Completion Date

Feb 28, 2022Estimated

First Submitted Date

Dec 22, 2021

First Submission Date that Met QC Criteria

Dec 22, 2021

First Posted Date

Jan 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

Dec 22, 2021

Last Update Posted Date

Jan 11, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

JiWon Han, assistant professor, Seoul National University Bundang HospitalPrincipal Investigator

Lead Sponsor

Seoul National University Bundang HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In patients with cerebral palsy, delayed gastric emptying and esophageal sphincter dysfunction are very commonly observed.

Pulmonary aspiration of gastric contents causes aspiration pneumonia, which greatly affects patients' prognosis, including hospital stay and mortality.

In the case of patients with cerebral palsy, there is a limitation in respiratory function, so more attention is required.

Therefore, this study aims to evaluate the risk of aspiration by measuring gastric volume after fasting for surgery in children with cerebral palsy.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

38Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ultrasound assessment	Diagnostic Test	gastric volume assessment by ultrasound

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
gastric volume	-7.8 + (3.5 x RLD CSA) + 0.127 X age (months)	preoperative 20 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with cerebral palsy under the age of 18 scheduled surgery under general anesthesia

Exclusion Criteria:

the patient who feed through Levin tube or gastrostomy tube
refusal to participate

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

patients with cerebral palsy under the age of 18 scheduled surgery under general anesthesia

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jiwon Han, Dr	Contact	82-10-3447-1988		yesuroon@gmail.com
Hyung-Jung Shin, Dr	Contact	82-31-787-7499		hjshin.anesth@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital	Recruiting	Seongnam-si	Gyeonggi-do	13620	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D002547	Cerebral Palsy

Ancestor Terms

ID	Term
D001925	Brain Damage, Chronic
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided