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NCT05810532 Clinical Trial

NPO Before Sedation

Pediatric ALL Clinical Trial

Official title:
Investigation on the Safety of 4-1 Hour Fasting Policy Before Sedation in Children.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05810532
Other study ID # NPO1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 4, 2023
Est. completion date December 11, 2023

Study information
Verified date April 2024
Source Kangbuk Samsung Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Pre-procedural fasting is routinely conducted to prevent pulmonary aspiration regarding sedation or anesthesia. However, prolonged fasting cause hypoglycemia, dehydration, nausea, and patient discomfort. Moreover, because children have small reserved energy, prolonged fasting need to be prohibited. Therefore, this study is designed to investigate the safety and efficacy of new fasting policy allowing water until 1 hour before sedation compared to the standard fasting time (4 hours of fasting including water).

Recruitment information / eligibility
Status Completed
Enrollment 68
Est. completion date December 11, 2023
Est. primary completion date December 11, 2023
Accepts healthy volunteers No
Gender All
Age group 1 Month to 3 Years
Eligibility Inclusion Criteria: - Children scheduled for elective echocardiography - Aged under 3 years old Exclusion Criteria: - Comorbidity other than hear disease or chromosomal disease - Patients with delayed gastric emptying - Patients with structural abnormalities of the stomach or esophagus - Difficult airway management - Parents refuse to participate in the study - Unable to achieve sedation - Neonatal

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• 4 hours of fasting time
Oral intake is not allowed for 4 hours before sedation including water
• 1 hour of fasting time
Oral intake is not allowed for 4 hours before sedation, while water is allowed to intake before 1 hour of sedation

Locations
Country Name City State
Korea, Republic of Kangbuk Samsung Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Kangbuk Samsung Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Gastric astral cross-sectional area Gastric astral cross-sectional area measured with gastric ultrasound 10 minutes before sedation
Secondary Estimated gastric volume Calculated gastric volume using the formula 10 minutes before sedation
Secondary Perlas grade Perlas grade 0 : no risk of aspiration, Perlas grade 1 : minimal risk of aspiration, Perlas grade 2: high risk of aspiration 10 minutes before sedation
Secondary Quality of sdeation 0, no response to pain; 1, slight response to pain; 2, response to pain; 3, response to calling 10 minutes after sedation
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