NCT05185336

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 11, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

February 10, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2022

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

January 11, 2022

Status Verified

December 1, 2021

Enrollment Period

Same day

First QC Date

December 22, 2021

Last Update Submit

December 22, 2021

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (1)

  • gastric volume

    -7.8 + (3.5 x RLD CSA) + 0.127 X age (months)

    preoperative 20 minutes

Interventions

ultrasound assessmentDIAGNOSTIC_TEST

gastric volume assessment by ultrasound

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Jiwon Han, Dr

CONTACT

82-10-3447-1988yesuroon@gmail.com

Hyung-Jung Shin, Dr

CONTACT

82-31-787-7499hjshin.anesth@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

December 22, 2021

First Posted

January 11, 2022

Study Start

February 10, 2022

Primary Completion

February 10, 2022

Study Completion

February 28, 2022

Last Updated

January 11, 2022

Record last verified: 2021-12

Locations

KR(1)