Cost Effectiveness of the EndoPhys Pressure Sensing Access System vs. Radial A-line for Intra-operative Blood Pressure Monitoring
Primary Purpose
Cerebrovascular Disorders
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
EndoPhys Sheath and Radial Arterial Line
EndoPhys Sheath
Sponsored by
About this trial
This is an interventional health services research trial for Cerebrovascular Disorders
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
EndoPhys Sheath and Radial Arterial Line
EndoPhys Sheath
Arm Description
This group of patients will have both the EndoPhys sheath and the radial arterial line placed during surgery.
This group of patients will only receive the EndoPhys sheath during surgery.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Difference in preparation time between the two approaches
Complication rates between the two groups.
Associated anticipated costs of complications between the two groups.
Patient satisfaction as assessed by post-operative questionnaire
Anesthesiologist satisfaction as assessed by post-operative questionnaire
Technical success of EndoPhys sheath for blood pressure measurement and accuracy as compared to the radial arterial line.
Sensitivity analysis to evaluated variation in times for arterial line placement
Sensitivity analysis to evaluated variable operating room time costs
Full Information
NCT ID
NCT03239847
First Posted
July 21, 2017
Last Updated
August 1, 2017
Sponsor
Vanderbilt University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03239847
Brief Title
Cost Effectiveness of the EndoPhys Pressure Sensing Access System vs. Radial A-line for Intra-operative Blood Pressure Monitoring
Official Title
Cost Effectiveness of the EndoPhys Pressure Sensing Access System vs. Radial A-line for Intra-operative Blood Pressure Monitoring
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
September 6, 2016 (Actual)
Primary Completion Date
April 5, 2017 (Actual)
Study Completion Date
April 5, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Disorders
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Care Provider
Masking Description
Anesthesia team will not be made aware of the purpose of the trial.
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EndoPhys Sheath and Radial Arterial Line
Arm Type
Experimental
Arm Description
This group of patients will have both the EndoPhys sheath and the radial arterial line placed during surgery.
Arm Title
EndoPhys Sheath
Arm Type
Experimental
Arm Description
This group of patients will only receive the EndoPhys sheath during surgery.
Intervention Type
Other
Intervention Name(s)
EndoPhys Sheath and Radial Arterial Line
Intervention Type
Other
Intervention Name(s)
EndoPhys Sheath
Primary Outcome Measure Information:
Title
Total Cost
Description
Total cost of each approach, as defined by the sum of material (device) costs plus the value of operative room time per minute.
Time Frame
Patient time in operating room (approximately 2 hours)
Secondary Outcome Measure Information:
Title
Difference in preparation time between the two approaches
Time Frame
From onset of anesthesia to successful insertion of the catheter (approximately 30 minutes)
Title
Complication rates between the two groups.
Time Frame
Patient time in operating room (approximately 2 hours)
Title
Associated anticipated costs of complications between the two groups.
Time Frame
Patient time in operating room (approximately 2 hours)
Title
Patient satisfaction as assessed by post-operative questionnaire
Time Frame
Questionnaire is assessed post-operatively at one day and at the 2-4 week follow up (approximately 5 minutes to assess)
Title
Anesthesiologist satisfaction as assessed by post-operative questionnaire
Time Frame
Questionnaire is assessed post-operatively in the operating room (approximately 5 minutes to assess)
Title
Technical success of EndoPhys sheath for blood pressure measurement and accuracy as compared to the radial arterial line.
Time Frame
Upon EndoPhys sheath insertion until it is removed from the femoral artery (approximately 1.5 hours)
Title
Sensitivity analysis to evaluated variation in times for arterial line placement
Time Frame
From onset of anesthesia to successful insertion of the catheter (approximately 30 minutes)
Title
Sensitivity analysis to evaluated variable operating room time costs
Time Frame
Patient time in operating room (approximately 2 hours)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael T Froehler, MD, PhD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29487193
Citation
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.
Results Reference
derived
Learn more about this trial
Cost Effectiveness of the EndoPhys Pressure Sensing Access System vs. Radial A-line for Intra-operative Blood Pressure Monitoring
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