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The goal of this pilot prospective cohort study is to examine the reproducibility of gastric volume and emptying as measured by gastric ultrasound and its correlation to a gold-standard test for gastric emptying in the perioperative period in pediatric patients. The main questions it aims to answer are:
The study will include two cohorts. Cohort assignment will be based on age and anesthesia induction plan. Subjects >7yrs of age and expected to get an IV induction will be assigned to Cohort #1. Subjects <7yrs of age and not expected to get an IV induction will be assigned to Cohort #2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 - ultrasound and acetaminophen | Cohort 1 will include subjects who have a peripheral intravenous line placed in the pre-op area per routine care. This cohort is on average age 7 years and older. Procedures for cohort 1 will include: (a) gastric US measurement of the antral CSA and gastric volume using the Perlas US qualitative grading assessment by an expert and a novice operator to determine the inter-rater class reliability and repeat measurements by each operator to assess the intra-rater reliability (Aim 1), and (b) serial abdominal ultrasounds for gastric assessment and the acetaminophen absorption test to determine the correlation between gastric US and a gold-standard for gastric emptying (Aim 2). The acetaminophen absorption test requires administering a single weight-based enteral dose of acetaminophen with 6 oz of water and drawing of blood samples through a peripheral intravenous line. |
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| Cohort 2 - ultrasound only | Cohort 2 will include subjects for whom a peripheral intravenous line placement is not part of routine pre-operative care. Average age for cohort 2 is age less than 7 years old. Procedures for Cohort 2 will include a gastric US measurement of the antral CSA and gastric volume using Perlas US qualitative grading assessment by an expert and a novice operator to determine the inter-rater class reliability and repeat measurements by each operator for the intra-rater reliability (Aim 1). This cohort is included to examine the reliability of measurements across age groups. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gastric Ultrasound Baseline Scans | Diagnostic Test | The patient's abdomen will be scanned using the ultrasound device by an expert scanner and novice scanner for baseline assessment of the antral CSA and gastric volume using Perlas US qualitative grading assessment. |
| Measure | Description | Time Frame |
|---|---|---|
| Inter-rater reliability | Measured using the following quantitative and qualitative ultrasound assessments between a novice and an expert gastric ultrasound operator:
| 1 year |
| Intra-rater reliability | Measured using the following quantitative and qualitative ultrasound assessments between a novice and an expert gastric ultrasound operator:
| 1 year |
| Gastric Emptying | Outcome will be gastric emptying assessed by the change in antral CSA (measured in cm2) over time after acetaminophen administration, and this will be correlated to gastric emptying over the same period of time by the acetaminophen absorption test PK parameter, AUC60 mcg*min/mL. As such, each patient will act as their own control. Correlation analysis will be applied to examine the performance of CSA measurements overtime using gastric ultrasound to determine gastric emptying compared to the acetaminophen absorption test as the gold standard. |
| Measure | Description | Time Frame |
|---|---|---|
| Post-anesthetic outcomes | Fasting times have been correlated to post-anesthetic outcomes such as post-operative nausea/ vomiting, and discomfort, and it is known that some patients fast longer than required by their clinical team, which can result in adverse effects. Reported fasting times for all patients and confirmatory assessment by gastric US will be examined along with data pulled from the medical record about post-operative nausea/ vomiting, post-operative discomfort, satisfaction, and whether the patient met their expected post-operative trajectory or not (e.g. unplanned admission). |
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Inclusion Criteria:
Exclusion Criteria:
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This study is enrolling healthy pediatric subjects ages 2 through 17 years of age who are undergoing surgery with anesthesia at Boston Children's Hospital.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jocelyn Booth, BSN | Contact | 857-218-4585 | jocelyn.booth@childrens.harvard.edu | |
| Rachel Bernier, MPH | Contact | 857-218-5348 | rachel.bernier@childrens.harvard.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25495405 | Result | 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. |
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| ID | Term |
|---|---|
| D005215 | Fasting |
| D018589 | Gastroparesis |
| D011015 | Pneumonia, Aspiration |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
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| Acetaminophen Absorption Test (AAT) | Diagnostic Test | Prior to starting the AAT, a baseline plasma acetaminophen level (250 microliters) will be obtained from the intravenous catheter. The subject will then be given 12.5 mg/kg or max 650mg of single batch 32mg/mL acetaminophen followed by 6oz of water PO. Up to 3 additional small volume blood samples will be drawn for acetaminophen levels. These additional blood samples (250 microliters each) will be obtained to measure acetaminophen plasma levels at the following goal intervals after acetaminophen administration.T1:10-20 mins, T2:35-45 mins, T3: 60mins. At the time of each lab draw gastric ultrasound will be assessed by the expert scanner to correlate gastric ultrasound with the acetaminophen absorption test as a gold-standard of gastric emptying. |
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| Gastric Ultrasound Serial Scans | Diagnostic Test | Cohort 1 will have multiple scans as part of assessing gastric emptying. These sequential scans after the baseline assessment will be done in line with the Acetaminophen Absorption Test timeline (T1:10-20 mins, T2:35-45 mins, T3: 60mins) and will be performed by an expert scanner only. |
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| 1 year |
| 1 year |
| D004066 |
| Digestive System Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |