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The primary objective of this study is to evaluate gastric volume and contents as well as gall bladder size in patients scheduled for routine, urgent, and emergency surgery. The hypothesis is that patients with stress, pain and opioid administration will have delayed gastric emptying and therefore a larger gastric fluid volume than those scheduled for elective surgery. The patients who have an appropriate NPO time will have a larger gallbladder size than the patients with shorter NPO time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Routine | Active Comparator | Patients who are scheduled for routine outpatient surgery. |
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| Urgent | Active Comparator | Patients who are scheduled for urgent surgery. |
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| Emergent | Active Comparator | Patients who are scheduled for emergency surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Point-of-Care Ultrasound | Device | Portable ultrasonography done at the bedside. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Aspiration Risk Grade | Grade 0: No fluid visible in the gastric antrum Grade 1: Clear fluid visualized with volume < 1.5 mL/kg Grade 2: Clear fluid visualized with volume > 1.5 mL/kg (High risk of aspiration) | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| NPO at the Time of Injury | Amount of time the patient was without food or water prior to their injury. This only applies to the Semi-urgent and Urgent groups. | Baseline |
| NPO at the Time of Surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Elective | Patients who are scheduled for routine outpatient surgery. Point-of-Care Ultrasound: Portable ultrasonography done at the bedside. |
| FG001 | Semi-urgent | Patients who are scheduled for semi-urgent surgery - within 6 hours of admission. Point-of-Care Ultrasound: Portable ultrasonography done at the bedside. |
| FG002 | Urgent | Patients who are scheduled for urgent surgery - within 2 hours of admission. Point-of-Care Ultrasound: Portable ultrasonography done at the bedside. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Elective | Patients who are scheduled for routine outpatient surgery. Point-of-Care Ultrasound: Portable ultrasonography done at the bedside. |
| BG001 | Semi-urgent | Patients who are scheduled for semi-urgent surgery - within 6 hours of admission. Point-of-Care Ultrasound: Portable ultrasonography done at the bedside. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Aspiration Risk Grade | Grade 0: No fluid visible in the gastric antrum Grade 1: Clear fluid visualized with volume < 1.5 mL/kg Grade 2: Clear fluid visualized with volume > 1.5 mL/kg (High risk of aspiration) | Posted | Count of Participants | Participants | Baseline |
|
24 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Elective | Patients who are scheduled for routine outpatient surgery. Point-of-Care Ultrasound: Portable ultrasonography done at the bedside. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alok Moharir | Nationwide Children's Hospital | 614-722-4200 | alok.moharir@nationwidechildrens.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 15, 2020 | Feb 8, 2023 | Prot_SAP_000.pdf |
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Amount of time the patient was without food or water prior to their surgery.
| Baseline |
| Pre-operative Opioid Administration | Patients who received opioids for pain control prior to surgery. | Baseline |
| BG002 | Urgent | Patients who are scheduled for urgent surgery - within 2 hours of admission. Point-of-Care Ultrasound: Portable ultrasonography done at the bedside. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
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| Weight | Mean | Standard Deviation | kilograms |
|
| BMI | Mean | Standard Deviation | kg/m2 |
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| American Society of Anesthesiologists (ASA) status | ASA I = Normal healthy patient, ASA II - Patient with mild systemic disease | Median | Inter-Quartile Range | units on a scale |
|
| OG002 |
| Urgent |
Patients who are scheduled for urgent surgery - within 2 hours of admission. Point-of-Care Ultrasound: Portable ultrasonography done at the bedside. |
|
|
| Secondary | NPO at the Time of Injury | Amount of time the patient was without food or water prior to their injury. This only applies to the Semi-urgent and Urgent groups. | Posted | Count of Participants | Participants | Baseline |
|
|
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| Secondary | NPO at the Time of Surgery | Amount of time the patient was without food or water prior to their surgery. | Posted | Count of Participants | Participants | Baseline |
|
|
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| Secondary | Pre-operative Opioid Administration | Patients who received opioids for pain control prior to surgery. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| 0 |
| 41 |
| 0 |
| 41 |
| 0 |
| 41 |
| EG001 | Semi-urgent | Patients who are scheduled for semi-urgent surgery - within 6 hours of admission. Point-of-Care Ultrasound: Portable ultrasonography done at the bedside. | 0 | 32 | 0 | 32 | 0 | 32 |
| EG002 | Urgent | Patients who are scheduled for urgent surgery - within 2 hours of admission. Point-of-Care Ultrasound: Portable ultrasonography done at the bedside. | 0 | 27 | 0 | 27 | 0 | 27 |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Title | Measurements |
|---|---|
|