Clinical trial NCT03239847: Cost Effectiveness of the EndoPhys Pressure Sensing Access System vs. Radial A-line for Intra-operative Blood Pressure Monitoring
Official title: Cost Effectiveness of the EndoPhys Pressure Sensing Access System vs. Radial A-line for Intra-operative Blood Pressure Monitoring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebrovascular Disorders
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2017-08-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Total Cost
timeFrame: Patient time in operating room (approximately 2 hours)
Secondary outcomes:
measure: Difference in preparation time between the two approaches
timeFrame: From onset of anesthesia to successful insertion of the catheter (approximately 30 minutes)
measure: Complication rates between the two groups.
timeFrame: Patient time in operating room (approximately 2 hours)
measure: Associated anticipated costs of complications between the two groups.
timeFrame: Patient time in operating room (approximately 2 hours)
measure: Patient satisfaction as assessed by post-operative questionnaire
timeFrame: Questionnaire is assessed post-operatively at one day and at the 2-4 week follow up (approximately 5 minutes to assess)
measure: Anesthesiologist satisfaction as assessed by post-operative questionnaire
timeFrame: Questionnaire is assessed post-operatively in the operating room (approximately 5 minutes to assess)
measure: Technical success of EndoPhys sheath for blood pressure measurement and accuracy as compared to the radial arterial line.
timeFrame: Upon EndoPhys sheath insertion until it is removed from the femoral artery (approximately 1.5 hours)
measure: Sensitivity analysis to evaluated variation in times for arterial line placement
timeFrame: From onset of anesthesia to successful insertion of the catheter (approximately 30 minutes)
measure: Sensitivity analysis to evaluated variable operating room time costs
timeFrame: Patient time in operating room (approximately 2 hours)
Other outcomes:
Locations:
Study officials:
affiliation: Vanderbilt University Medical Center
name: Michael T Froehler, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.