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Investigators have started an awake spinal anesthesia program in conjunction with pediatric surgical colleagues. Patients are offered the option of awake spinal anesthesia instead of general anesthesia for appropriate surgical procedures. Previous studies have demonstrated a lack of significant hemodynamic changes in neonates and infants following spinal anesthesia; however, there are limited data regarding its impact on tissue oxygenation. The goal of the current study is to assess changes in tissue and cerebral oxygenation using non-invasive near infrared spectroscopy following spinal anesthesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NIRS | Experimental | Non-invasive near infrared spectroscopy to assess changes in tissue and cerebral oxygenation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NIRS | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cerebral Non-invasive Near Infrared Spectroscopy (NIRS) | Change in cerebral oxygen saturation from immediately after spinal anesthesia placement to conclusion of monitoring (30 mins post block). | Intraoperative measure |
| Tissue Non-invasive Near Infrared Spectroscopy (NIRS) | Change in tissue oxygen saturation from immediately after spinal anesthesia placement to conclusion of monitoring (30 mins post block). | Intraoperative measure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Tobias, MD | Nationwide Children's Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29330639 | Derived | Froyshteter AB, Tumin D, Whitaker EE, Martin DP, Hakim M, Walia H, Bhalla T, Tobias JD. Changes in tissue and cerebral oxygenation following spinal anesthesia in infants: a prospective study. J Anesth. 2018 Apr;32(2):288-292. doi: 10.1007/s00540-017-2446-8. Epub 2018 Jan 12. |
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| ID | Title | Description |
|---|---|---|
| FG000 | NIRS | Non-invasive near infrared spectroscopy to assess changes in tissue and cerebral oxygenation. NIRS |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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4 subjects had unsuccessful blocks
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| ID | Title | Description |
|---|---|---|
| BG000 | NIRS | Non-invasive near infrared spectroscopy to assess changes in tissue and cerebral oxygenation. NIRS |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Cerebral Non-invasive Near Infrared Spectroscopy (NIRS) | Change in cerebral oxygen saturation from immediately after spinal anesthesia placement to conclusion of monitoring (30 mins post block). | Posted | Number | 95% Confidence Interval | percentage change per minute | Intraoperative measure |
|
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Until discharge to home, approximately 2 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 | NIRS | Non-invasive near infrared spectroscopy to assess changes in tissue and cerebral oxygenation. NIRS |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joseph D. Tobias, MD | Nationwide Children's Hospital | 614-722-4200 | Joseph.Tobias@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 | Jun 14, 2016 | Aug 14, 2018 | Prot_SAP_000.pdf |
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| months |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Primary | Tissue Non-invasive Near Infrared Spectroscopy (NIRS) | Change in tissue oxygen saturation from immediately after spinal anesthesia placement to conclusion of monitoring (30 mins post block). | Posted | Number | 95% Confidence Interval | percentage change per minute | Intraoperative measure |
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| 23 |
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| 23 |
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