Pulmonary Aspiration of Gastric Contents Clinical Trial
— ENGUSOfficial title:
Gastric Content After 6 vs 4 Hours of Preoperative Fasting in Children on Enteral Nutrition. A Randomized Controlled Trial Using Gastric Ultrasound
| NCT number | NCT05695066 |
| Other study ID # | ENGUS |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | January 23, 2023 |
| Est. completion date | October 2025 |
The primary objective of the study is to compare the risk of increased stomach contents after tube feeding (Enteral feeding) 6 and 4 hours before anesthesia using antrum measured by ultrasound.
| Status | Recruiting |
| Enrollment | 180 |
| Est. completion date | October 2025 |
| Est. primary completion date | May 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 6 Months to 12 Years |
| Eligibility | Inclusion Criteria: Child on intermittent or continuous enteral nutrition, scheduled for elective procedure requiring general anesthesia Exclusion Criteria: Moderate to severe gastrointestinal motility disorder Emergency surgery Anatomical risk factor for pulmonary aspiration such as achalasia or bowel obstruction Parents cannot understand study information due to language barrier |
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Uppsala University Hospital | Uppsala |
| Lead Sponsor | Collaborator |
|---|---|
| Uppsala University Hospital |
Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | CSA | Gastric antral surface area | Immediately before anesthesia induction | |
| Secondary | Suctioned GCV | Gastric content volume suctioned through nasogastric tube after induction | Immediately after intubation |
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