Pediatric ALL
Conditions
Brief 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).
Interventions
Oral intake is not allowed for 4 hours before sedation including water
OTHER1 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
Sponsors
Kangbuk Samsung Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Months to 3 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gastric astral cross-sectional area | 10 minutes before sedation | Gastric astral cross-sectional area measured with gastric ultrasound |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Estimated gastric volume | 10 minutes before sedation | Calculated gastric volume using the formula |
| Perlas grade | 10 minutes before sedation | Perlas grade 0 : no risk of aspiration, Perlas grade 1 : minimal risk of aspiration, Perlas grade 2: high risk of aspiration |
| Quality of sdeation | 10 minutes after sedation | 0, no response to pain; 1, slight response to pain; 2, response to pain; 3, response to calling |
Countries
South Korea
Outcome results
None listed