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

Cerebrovascular Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03239847
• Other study ID #: 160877
• Status: Completed
• Phase: N/A
• First received: July 21, 2017
• Last updated: August 1, 2017
• Start date: September 6, 2016
• Est. completion date: April 5, 2017

Study information

• Verified date: August 2017
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 5, 2017
• Est. primary completion date: April 5, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebrovascular Disorders

Intervention

Other:
• EndoPhys Sheath and Radial Arterial Line

• EndoPhys Sheath

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Difference in preparation time between the two approaches		From onset of anesthesia to successful insertion of the catheter (approximately 30 minutes)
Secondary	Complication rates between the two groups.		Patient time in operating room (approximately 2 hours)
Secondary	Associated anticipated costs of complications between the two groups.		Patient time in operating room (approximately 2 hours)
Secondary	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)
Secondary	Anesthesiologist satisfaction as assessed by post-operative questionnaire		Questionnaire is assessed post-operatively in the operating room (approximately 5 minutes to assess)
Secondary	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)
Secondary	Sensitivity analysis to evaluated variation in times for arterial line placement		From onset of anesthesia to successful insertion of the catheter (approximately 30 minutes)
Secondary	Sensitivity analysis to evaluated variable operating room time costs		Patient time in operating room (approximately 2 hours)