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

Vanderbilt University Medical Center40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Enrollment

Conditions

Cerebrovascular Disorders

Interventions

EndoPhys Sheath and Radial Arterial LineOTHER

EndoPhys SheathOTHER

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Patient time in operating room (approximately 2 hours)

Secondary Outcomes

Difference in preparation time between the two approaches

Time frame: From onset of anesthesia to successful insertion of the catheter (approximately 30 minutes)

Complication rates between the two groups.

Time frame: Patient time in operating room (approximately 2 hours)

Associated anticipated costs of complications between the two groups.

Time frame: Patient time in operating room (approximately 2 hours)

Patient satisfaction as assessed by post-operative questionnaire

Time frame: 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

Time frame: 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.

Time frame: 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

Time frame: From onset of anesthesia to successful insertion of the catheter (approximately 30 minutes)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.