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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05185336
Other study ID # B-2104-681-301
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 10, 2022
Est. completion date February 28, 2022

Study information

Verified date December 2021
Source Seoul National University Bundang Hospital
Contact Jiwon Han, Dr
Phone 82-10-3447-1988
Email yesuroon@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 38
Est. completion date February 28, 2022
Est. primary completion date February 10, 2022
Accepts healthy volunteers No
Gender All
Age group 1 Year to 18 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
ultrasound assessment
gastric volume assessment by ultrasound

Locations

Country Name City State
Korea, Republic of Seoul National University Bundang Hospital Seongnam-si Gyeonggi-do

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary gastric volume -7.8 + (3.5 x RLD CSA) + 0.127 X age (months) preoperative 20 minutes
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