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This study aims to compare the time difference between radial arterial line placement and use of the EndoPhys sheath, as well as, assess the cost effectiveness of the EnoPhys sheath vs. use of a radial arterial line based on device and operating room costs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EndoPhys Sheath and Radial Arterial Line | Experimental | This group of patients will have both the EndoPhys sheath and the radial arterial line placed during surgery. |
|
| EndoPhys Sheath | Experimental | This group of patients will only receive the EndoPhys sheath during surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EndoPhys Sheath and Radial Arterial Line | Other |
| ||
| EndoPhys Sheath |
| Measure | Description | Time Frame |
|---|---|---|
| Total Cost | Total cost of each approach, as defined by the sum of material (device) costs plus the value of operative room time per minute. | Patient time in operating room (approximately 2 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in preparation time between the two approaches | From onset of anesthesia to successful insertion of the catheter (approximately 30 minutes) | |
| Complication rates between the two groups. | Patient time in operating room (approximately 2 hours) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael T Froehler, MD, PhD | Vanderbilt University Medical Center | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29487193 | Derived | Froehler MT, Chitale R, Magarik JA, Fusco MR. Comparison of a pressure-sensing sheath and radial arterial line for intraoperative blood pressure monitoring in neurointerventional procedures. J Neurointerv Surg. 2018 Aug;10(8):784-787. doi: 10.1136/neurintsurg-2018-013769. Epub 2018 Feb 27. |
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Anesthesia team will not be made aware of the purpose of the trial.
| Other |
|
| Associated anticipated costs of complications between the two groups. | Patient time in operating room (approximately 2 hours) |
| Patient satisfaction as assessed by post-operative questionnaire | Questionnaire is assessed post-operatively at one day and at the 2-4 week follow up (approximately 5 minutes to assess) |
| Anesthesiologist satisfaction as assessed by post-operative questionnaire | Questionnaire is assessed post-operatively in the operating room (approximately 5 minutes to assess) |
| Technical success of EndoPhys sheath for blood pressure measurement and accuracy as compared to the radial arterial line. | Upon EndoPhys sheath insertion until it is removed from the femoral artery (approximately 1.5 hours) |
| Sensitivity analysis to evaluated variation in times for arterial line placement | From onset of anesthesia to successful insertion of the catheter (approximately 30 minutes) |
| Sensitivity analysis to evaluated variable operating room time costs | Patient time in operating room (approximately 2 hours) |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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