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

NCT03239847 | Completed

• 1 other identifier: 160877
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cerebrovascular Disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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)

Study Arms (2)

EndoPhys Sheath and Radial Arterial Line

EXPERIMENTAL

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

EndoPhys Sheath

EXPERIMENTAL

This group of patients will only receive the EndoPhys sheath during surgery.

Other: EndoPhys Sheath

Interventions

EndoPhys Sheath and Radial Arterial Line OTHER

EndoPhys Sheath and Radial Arterial Line

EndoPhys Sheath OTHER

EndoPhys Sheath

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All elective neuro endovascular procedures requiring general anesthesia and continuous invasive blood pressure monitoring
• Adequate access to both the radial or femoral artery

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Related Publications (1)

• 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.

  PMID: 29487193 DERIVED

MeSH Terms

Conditions

Cerebrovascular Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Michael T Froehler, MD, PhD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Anesthesia team will not be made aware of the purpose of the trial.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Professor

Study Record Dates

• First Submitted: July 21, 2017
• First Posted: August 4, 2017
• Study Start: September 6, 2016
• Primary Completion: April 5, 2017
• Study Completion: April 5, 2017
• Last Updated: August 4, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share