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OpenTrials
Completed

NCT Number: NCT03239847

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

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.

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Key information

Conditions

Cerebrovascular Disorders Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EndoPhys Sheath and Radial Arterial Line

Other

EndoPhys Sheath

Other

Primary outcomes

  1. Total Cost

    Time frame: 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 outcomes

  1. Difference in preparation time between the two approaches

    Time frame: From onset of anesthesia to successful insertion of the catheter (approximately 30 minutes)

  2. Complication rates between the two groups.

    Time frame: Patient time in operating room (approximately 2 hours)

  3. Associated anticipated costs of complications between the two groups.

    Time frame: Patient time in operating room (approximately 2 hours)

  4. 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)

  5. Anesthesiologist satisfaction as assessed by post-operative questionnaire

    Time frame: Questionnaire is assessed post-operatively in the operating room (approximately 5 minutes to assess)

  6. 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)

  7. 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)

  8. Sensitivity analysis to evaluated variable operating room time costs

    Time frame: Patient time in operating room (approximately 2 hours)

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 4, 2017
Registry last updated
Aug 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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