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Comparison of residual gastric volume measure by ultrasounds between diabetic and non-diabetic patients scheduled for elective surgery
The presence of gastric content increases the risk of aspiration during general anesthesia. Delayed gastric emptying has been described in diabetic patients; for that reason, diabetic patients could have a high risk of aspiration despite adequate fasting. This study aimed to compare ultrasound-guided measurement of residual gastric volume between diabetic and non-diabetic patients scheduled for elective surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diabetic patients | Diabetic patients undergoing scheduled surgery | ||
| Non-diabetic patients | Non-diabetic patients undergoing sheduled surgery |
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| Measure | Description | Time Frame |
|---|---|---|
| Residual Gastric Volume | Residual gastric volume measured by ultrasounds as follows: Volume (mL) = 27.0 + 14.6 × CSARLD (cm²) - 1.28 × age (years) | Preoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Antral Cross-Sectional Area | Antral cross-sectional area measured by ultrasounds | Preoperative |
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Inclusion Criteria:
Exclusion Criteria:
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Fasted diabetic and non-diabetic patients scheduled for surgery.
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| Name | Affiliation | Role |
|---|---|---|
| José A. Sastre, MD, PhD | Anesthesiology Service. Salamanca University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IBSAL | Salamanca | 37007 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39116006 | Result | Sastre JA, Lopez T, Julian R, Bustos D, Sanchis-Dux R, Molero-Diez YB, Sanchez-Tabernero A, Ruiz-Simon FA, Sanchez-Hernandez MV, Gomez-Rios MA. Assessing Full Stomach Prevalence with Ultrasound Following Preoperative Fasting in Diabetic Patients with Dysautonomia: A Comparative Observational Study. Anesth Analg. 2024 Dec 1;139(6):1300-1308. doi: 10.1213/ANE.0000000000007110. Epub 2024 Aug 8. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Diabetic Patients | Diabetic patients undergoing scheduled surgery |
| FG001 | Non-diabetic Patients | Non-diabetic patients undergoing sheduled surgery |
| FG002 | Diabetic Patients With Dysautonomia | Diabetic patients with dysautonomia undergoing surgery |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Diabetic Patients | Diabetic patients undergoing scheduled surgery |
| BG001 | Non-diabetic Patients | Non-diabetic patients undergoing sheduled surgery |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Residual Gastric Volume | Residual gastric volume measured by ultrasounds as follows: Volume (mL) = 27.0 + 14.6 × CSARLD (cm²) - 1.28 × age (years) | Posted | Median | Inter-Quartile Range | mL | Preoperative |
|
1 day
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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 | Diabetic Patients | Diabetic patients undergoing scheduled surgery | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. José A. Sastre | Hospital Universitario de Salamanca | 0034923291100 | 55580 | jasastre@saludcastillayleon.es |
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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 | Mar 23, 2022 | Mar 23, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| BG002 | Diabetic Patients With Dysautonomia | Diabetic patients with dysautonomia undergoing scheduled surgery |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
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|
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| Secondary | Antral Cross-Sectional Area | Antral cross-sectional area measured by ultrasounds | Posted | Median | Inter-Quartile Range | cm2 | Preoperative |
|
|
|
|
| 216 |
| 0 |
| 216 |
| 0 |
| 216 |
| EG001 | Non-diabetic Patients | Non-diabetic patients undergoing sheduled surgery | 0 | 144 | 0 | 144 | 0 | 144 |
| EG002 | Diabetic Patients With Dysautonomia | Diabetic patients with dysautonomia undergoing scheduled surgery | 0 | 221 | 0 | 221 | 0 | 221 |
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