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NCT04918277 Clinical Trial

Gastric Volume in the Fasted Pediatric Cerebral Palsy Patients

Cerebral Palsy Clinical Trial

Official title:
Ultrasound Assessment of Gastric Volume and Aspiration Risk Evaluation in the Fasted Pediatric Cerebral Palsy Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04918277
Other study ID # L-2021-365
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 5, 2021
Est. completion date August 30, 2022

Study information
Verified date June 2021
Source Seoul National University Bundang Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

In children with cerebral palsy, the gastric volume is measured through ultrasound after fasting before surgery to evaluate whether the risk of aspiration is higher than that of the general population.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 38
Est. completion date August 30, 2022
Est. primary completion date May 30, 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 undergoing surgery under general anesthesia Exclusion Criteria: - Levin tube or gastrostomy tube in situ - Decline to participate

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Assessment of gastric volume
Measuring the cross-sectional area of stomach in supine and right lateral decubitus

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Bundang Hospital

References & Publications (1)

Spencer AO, Walker AM, Yeung AK, Lardner DR, Yee K, Mulvey JM, Perlas A. Ultrasound assessment of gastric volume in the fasted pediatric patient undergoing upper gastrointestinal endoscopy: development of a predictive model using endoscopically suctioned volumes. Paediatr Anaesth. 2015 Mar;25(3):301-8. doi: 10.1111/pan.12581. Epub 2014 Dec 11. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary gastric volume Volume = -7.8 + (3.5 x RLD CSA) + 0.127 X age (months) preoperative 1 days to postoperative 1 days
Secondary Grade of gastric fullness Grade 0: Neither in supine, right lateral decubitus / Grade 1: stomach content only in lateral decubitus , Grade 2: Both in supine, lateral decubitus preoperative 1 days to postoperative 1 days
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