Cost Effectiveness of the EndoPhys Pressure Sensing Access System vs. Radial A-line for Intra-operative Blood Pressure Monitoring

Study Overview
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Brief Summary
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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.

Official Title
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Cost Effectiveness of the EndoPhys Pressure Sensing Access System vs. Radial A-line for Intra-operative Blood Pressure Monitoring

Conditions
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Cerebrovascular Disorders

Intervention / Treatment
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* Other: EndoPhys Sheath and Radial Arterial Line
* Other: EndoPhys Sheath


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All elective neuro endovascular procedures requiring general anesthesia and continuous invasive blood pressure monitoring Adequate access to both the radial or femoral artery Exclusion Criteria: Pre-operative identification of contra-indication for radial arterial line placement Hemodynamic instability Need for continued post-operative invasive blood pressure monitoring Failure to obtain informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EndoPhys Sheath and Radial Arterial Line<br>This group of patients will have both the EndoPhys sheath and the radial arterial line placed during surgery. | Other: EndoPhys Sheath and Radial Arterial Line<br> <br> |
| Experimental: EndoPhys Sheath<br>This group of patients will only receive the EndoPhys sheath during surgery. | Other: EndoPhys Sheath<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 
| 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) |