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

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 Overview

• Status: Completed
• Conditions: Cerebrovascular Disorders
• Intervention / Treatment: Other: EndoPhys Sheath and Radial Arterial Line; Other: EndoPhys Sheath

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: NON_RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: EndoPhys Sheath and Radial Arterial Line; This group of patients will have both the EndoPhys sheath and the radial arterial line placed during surgery.	Other: EndoPhys Sheath and Radial Arterial Line
EXPERIMENTAL: EndoPhys Sheath; This group of patients will only receive the EndoPhys sheath during surgery.	Other: EndoPhys Sheath

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Patient time in operating room (approximately 2 hours)

Secondary Outcome Measures

Outcome Measure	Time Frame
Difference in preparation time between the two approaches	From onset of anesthesia to successful insertion of the catheter (approximately 30 minutes)
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)
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)

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Principal Investigator: Michael T Froehler, MD, PhD, Vanderbilt University Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 6, 2016
• Primary Completion (ACTUAL): April 5, 2017
• Study Completion (ACTUAL): April 5, 2017

Study Registration Dates

• First Submitted: July 21, 2017
• First Submitted That Met QC Criteria: August 1, 2017
• First Posted (ACTUAL): August 4, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 4, 2017
• Last Update Submitted That Met QC Criteria: August 1, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebrovascular Disorders
• Other Study ID Numbers: 160877

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No