Cerebrovascular Disorders
Conditions
Brief summary
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.
Interventions
OTHEREndoPhys Sheath and Radial Arterial Line
OTHEREndoPhys Sheath
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Caregiver)
Masking description
Anesthesia team will not be made aware of the purpose of the trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Cost | Patient time in operating room (approximately 2 hours) | Total cost of each approach, as defined by the sum of material (device) costs plus the value of operative room time per minute. |
Secondary
| Measure | Time frame |
|---|---|
| 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) |
| Difference in preparation time between the two approaches | From onset of anesthesia to successful insertion of the catheter (approximately 30 minutes) |
| 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) |
| Anesthesiologist satisfaction as assessed by post-operative questionnaire | Questionnaire is assessed post-operatively in the operating room (approximately 5 minutes to assess) |
Outcome results
None listed