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

Vanderbilt University Medical Center

Status: Completed

Conditions: Cerebrovascular Disorders

Treatments: Other: EndoPhys Sheath and Radial Arterial Line; Other: EndoPhys Sheath

Study type: Interventional

Funder types: Other

Identifiers

NCT03239847

160877

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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40 participants in 2 patient groups

EndoPhys Sheath and Radial Arterial Line

Experimental group

Description:

This group of patients will have both the EndoPhys sheath and the radial arterial line placed during surgery.

Treatment:

Other: EndoPhys Sheath and Radial Arterial Line

EndoPhys Sheath

Experimental group

Description:

This group of patients will only receive the EndoPhys sheath during surgery.

Treatment:

Other: EndoPhys Sheath