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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.
Children must fast for a certain period of time before anesthesia and surgery to reduce the risk of food residues being vomited up and ending up in the trachea (so-called aspiration). But there are disadvantages to fasting for a long time before an operation, for example the blood sugar level can drop and the body can become dehydrated. Small children risk such side effects to a greater degree than adults, and therefore international work is underway to revise the rules for fasting before surgery.
Enteral feeding children are a special risk group because they are usually completely dependent on tube feeding for nutrition and fluid intake.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4H group | Experimental | Patients parents instructed to stop enteral feeding 4 hours before predicted anesthesia induction |
|
| 6H group | Active Comparator | Patients parents instructed to stop enteral feeding 6 hours before predicted anesthesia induction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preoperative fasting instruction | Procedure | Patients parents instructed to stop enteral feeding at a specified time before predicted anesthesia induction |
|
| Measure | Description | Time Frame |
|---|---|---|
| CSA | Gastric antral surface area | Immediately before anesthesia induction |
| Measure | Description | Time Frame |
|---|---|---|
| Suctioned GCV | Gastric content volume suctioned through nasogastric tube after induction | Immediately after intubation |
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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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peter Frykholm, MD, PhD | Contact | +46186171240 | peter.frykholm@surgsci.uu.se | |
| Ali-Reza Modiri, PhD | Contact | +46727411410 | ali-reza.modiri@uu.se |
| Name | Affiliation | Role |
|---|---|---|
| Peter Frykholm, MD PhD | Uppsala University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uppsala University Hospital | Recruiting | Uppsala | 75185 | Sweden |
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| Label | URL |
|---|---|
| Pre-operative fasting in children: A guideline from the European Society of Anaesthesiology and Intensive Care | View source |
| Ultrasound assessment of gastric emptying time after a standardised light breakfast in healthy children: A prospective observational study. | View source |
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| ID | Term |
|---|---|
| D063466 | Respiratory Aspiration of Gastric Contents |
| ID | Term |
|---|---|
| D057045 | Laryngopharyngeal Reflux |
| D005764 | Gastroesophageal Reflux |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
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Randomized controlled trial.
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Computerized randomization. Randomization outcome distributed via sealed envelopes. Randomization key stored on secure server.
| Gastric content assessed with gastric ultrasound in paediatric patients prescribed a light breakfast prior to general anaesthesia: A prospective observational study. |
| View source |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D053120 | Respiratory Aspiration |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |