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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

About this trial

This is an interventional health services research trial for Cerebrovascular Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

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

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

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

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