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

Not Applicable

Completed

• Conditions: Cerebrovascular Disorders
• Interventions: Other: EndoPhys Sheath and Radial Arterial Line; Other: EndoPhys Sheath

• Registration Number: NCT03239847
• Lead Sponsor: Vanderbilt University Medical Center

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2016-09-06
• Primary Completion: 2017-04-05
• Study Completion: 2017-04-05
• Study First Submitted: 2017-07-21
• Status Verified: 2017-08
• Study First Submitted QC: 2017-08-01
• Last Update Submitted: 2017-08-01
• Study First Posted: 2017-08-04
• Last Update Posted: 2017-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
EndoPhys Sheath and Radial Arterial Line	EndoPhys Sheath and Radial Arterial Line	This group of patients will have both the EndoPhys sheath and the radial arterial line placed during surgery.
EndoPhys Sheath	EndoPhys Sheath	This group of patients will only receive the EndoPhys sheath during surgery.

Primary Outcome Measures

Name	Time	Method
Total Cost	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 Outcome Measures

Name	Time	Method
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)