Cerebrovascular DisordersNCT03239847
Cost Effectiveness of the EndoPhys Pressure Sensing Access System vs. Radial A-line for Intra-operative Blood Pressure Monitoring
A study testing EndoPhys Sheath and Radial Arterial Line and EndoPhys Sheath in people with Cerebrovascular Disorders, run by Vanderbilt University Medical Center.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebrovascular Disorders
- What is being tested?
- EndoPhys Sheath and Radial Arterial Line and EndoPhys Sheath
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 6 Sep 2016to 5 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All elective neuro endovascular procedures requiring general anesthesia and continuous invasive blood pressure monitoring
- Adequate access to both the radial or femoral artery
Who cannot join
- 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
About this study
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
- Being tested
- EndoPhys Sheath and Radial Arterial Line, EndoPhys Sheath
- Medical subject headings
- Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoPhys Sheath and Radial Arterial LineOther
EndoPhys SheathOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: EndoPhys Sheath and Radial Arterial Line |
| EndoPhys Sheath | Experimental | This group of patients will only receive the EndoPhys sheath during surgery. Receives: Other: EndoPhys Sheath |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Patient time in operating room (approximately 2 hours)
Secondary outcomes (8)
Difference in preparation time between the two approaches
Measured: From onset of anesthesia to successful insertion of the catheter (approximately 30 minutes)
Complication rates between the two groups.
Measured: Patient time in operating room (approximately 2 hours)
Associated anticipated costs of complications between the two groups.
Measured: Patient time in operating room (approximately 2 hours)
Patient satisfaction as assessed by post-operative questionnaire
Measured: 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
Measured: Questionnaire is assessed post-operatively in the operating room (approximately 5 minutes to assess)
Technical success of EndoPhys sheath for blood pressure measurement and accuracy as compared to the radial arterial line.
Measured: Upon EndoPhys sheath insertion until it is removed from the femoral artery (approximately 1.5 hours)
Sensitivity analysis to evaluated variation in times for arterial line placement
Measured: From onset of anesthesia to successful insertion of the catheter (approximately 30 minutes)
Sensitivity analysis to evaluated variable operating room time costs
Measured: Patient time in operating room (approximately 2 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2017
- Study start6 Sep 2016
- Primary completion5 Apr 2017
- Study completion5 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular DisordersStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Froehler, Vanderbilt University Medical Center
- Investigators
- Michael T Froehler, MD, PhD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03239847
- Sponsor's protocol ID
- 160877
- Status last verified
- Aug 2017
- First submitted
- 21 Jul 2017
- Last updated
- 4 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29487193
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost Effectiveness of the EndoPhys Pressure Sensing Access System vs. Radial A-line for Intra-operative Blood Pressure Monitoring
- ClinicalTrials.gov ID
- NCT03239847
- Acronym / sponsor ID
- 160877
- Conditions
- Cerebrovascular Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 6 Sep 2016 (actual)
- Primary completion
- 5 Apr 2017 (actual)
- Study completion
- 5 Apr 2017 (actual)
- First posted
- 4 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EndoPhys Sheath and Radial Arterial Line | Experimental | Other: EndoPhys Sheath and Radial Arterial LineThis group of patients will have both the EndoPhys sheath and the radial arterial line placed during surgery. |
| EndoPhys Sheath | Experimental | Other: EndoPhys SheathThis group of patients will only receive the EndoPhys sheath during surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All elective neuro endovascular procedures requiring general anesthesia and continuous invasive blood pressure monitoring
- Adequate access to both the radial or femoral artery
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EndoPhys Sheath and Radial Arterial Line | Other | EndoPhys Sheath and Radial Arterial Line |
| EndoPhys Sheath | Other | EndoPhys Sheath |
Primary outcome
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.
8 secondary outcomes
Difference in preparation time between the two approaches
Time frame: From onset of anesthesia to successful insertion of the catheter (approximately 30 minutes)
Complication rates between the two groups.
Time frame: Patient time in operating room (approximately 2 hours)
Associated anticipated costs of complications between the two groups.
Time frame: Patient time in operating room (approximately 2 hours)
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)
Anesthesiologist satisfaction as assessed by post-operative questionnaire
Time frame: Questionnaire is assessed post-operatively in the operating room (approximately 5 minutes to assess)
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)
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)
Sensitivity analysis to evaluated variable operating room time costs
Time frame: Patient time in operating room (approximately 2 hours)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2017.
- Derived from this study: PubMed 29487193Froehler 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael T Froehler, MD, PhD principal investigator
Vanderbilt University Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing EndoPhys Sheath and Radial Arterial Line and EndoPhys Sheath in people with Cerebrovascular Disorders, run by Vanderbilt University Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Cost (time frame: Patient time in operating room (approximately 2 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03239847, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2017.