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Although the current standard for lumbar puncture and spinal anesthesia is the use of manual palpation of surface landmarks to identify the correct interspace, performance of the procedure at too high of a level may increase the incidence of adverse effects. The current study will evaluate the efficacy of ultrasound in identifying the correct intervertebral space for lumbar puncture thereby improving the safety of the procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spinal anesthesia | Experimental | Infants receiving spinal anesthesia for standard of care procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound | Diagnostic Test | Ultrasound to locate the appropriate lumbar interspace to perform spinal anesthesia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intended Interspace | The vertebral interspace that the anesthesia provider believes that they had marked & identified by manual palpation | Immediately prior to spinal anesthesia |
| Actual Interspace of Provider's Mark | The actual vertebral interspace that the anesthesia provider marked & identified, as verified by ultrasound. | Immediately prior to spinal anesthesia |
| Measure | Description | Time Frame |
|---|---|---|
| Level of Conus Medullaris - Sitting | Assessing the level of the conus medullaris by ultrasound in the sitting position. | Immediately prior to spinal anesthesia |
| Time to Mark | The amount of time if took for the anesthesia provider to manually palpate and mark the desired interspace. |
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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 | Spinal Anesthesia | Infants receiving spinal anesthesia for standard of care procedure Ultrasound: Ultrasound to locate the appropriate lumbar interspace to perform spinal anesthesia. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Spinal Anesthesia | Infants receiving spinal anesthesia for standard of care procedure Ultrasound: Ultrasound to locate the appropriate lumbar interspace to perform spinal anesthesia. |
| 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 | Intended Interspace | The vertebral interspace that the anesthesia provider believes that they had marked & identified by manual palpation | Posted | Count of Participants | Participants | Immediately prior to spinal anesthesia |
|
|
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 | Spinal Anesthesia | Infants receiving spinal anesthesia for standard of care procedure Ultrasound: Ultrasound to locate the appropriate lumbar interspace to perform spinal anesthesia. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Giorgio Veneziano, MD | Nationwide Children's Hospital | 614-722-4200 | Giorgio.Veneziano@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 | Jul 8, 2021 | Aug 16, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Immediately prior to spinal anesthesia |
| Time to Conduct Ultrasound | The amount of time it took for the investigator to identify the actual space that the provider marked using ultrasound. | Immediately prior to spinal anesthesia |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Median | Inter-Quartile Range | centimeters |
|
| Weight | Median | Inter-Quartile Range | kilograms |
|
| American Society of Anesthesiologists (ASA) status | The ASA score is a subjective assessment of a patient's overall health that is based on five classes (I to V): I = Patient is a completely healthy fit patient. II = Patient has mild systemic disease. III = Patient has severe systemic disease that is not incapacitating. IV = Patient has incapacitating disease that is a constant threat to life. V = A moribund patient who is not expected to live 24 hours with or without surgery. | Count of Participants | Participants |
|
|
| Primary | Actual Interspace of Provider's Mark | The actual vertebral interspace that the anesthesia provider marked & identified, as verified by ultrasound. | Posted | Count of Participants | Participants | Immediately prior to spinal anesthesia |
|
|
|
| Secondary | Level of Conus Medullaris - Sitting | Assessing the level of the conus medullaris by ultrasound in the sitting position. | Posted | Count of Participants | Participants | Immediately prior to spinal anesthesia |
|
|
|
| Secondary | Time to Mark | The amount of time if took for the anesthesia provider to manually palpate and mark the desired interspace. | Posted | Median | Inter-Quartile Range | seconds | Immediately prior to spinal anesthesia |
|
|
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| Secondary | Time to Conduct Ultrasound | The amount of time it took for the investigator to identify the actual space that the provider marked using ultrasound. | Posted | Median | Inter-Quartile Range | seconds | Immediately prior to spinal anesthesia |
|
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| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
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| L3-4 |
|
| Unable to obtain |
|