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

Vanderbilt University Medical Center0 sites40 target enrollmentSeptember 6, 2016

ConditionsCerebrovascular Disorders

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cerebrovascular Disorders
Sponsor: Vanderbilt University Medical Center
Enrollment: 40
Primary Endpoint: Total Cost
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 6, 2016

End Date

April 5, 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Vanderbilt University Medical Center

Responsible Party

Principal Investigator

Michael Froehler

Asst. Professor

Vanderbilt University Medical Center

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

Outcomes

Primary Outcomes

Total Cost

Time Frame: 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 Outcomes

Difference in preparation time between the two approaches(From onset of anesthesia to successful insertion of the catheter (approximately 30 minutes))
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))
Complication rates between the two groups.(Patient time in operating room (approximately 2 hours))