Central Venous Catheterization in Obese Patients With Compass Device
Conditions: Blood Pressure
Sponsor: University of New Mexico

Compass Device Trial
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Revised: February 14, 2017
PROTOCOL TITLE:
Central venous catheterization in obese patients with Compass device.
Brief title: Compass Device Trial
PRINCIPAL INVESTIGATOR:
Neal Gerstein, MD
Anesthesiology & Critical Care Medicine
272-2610
ngerstein@salud.unm.edu
VERSION NUMBER:
2.
DATE:
February 13, 2017.

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Table of Contents
1.0
Objectives* ...............................................................................................................3
2.0
Background*.............................................................................................................3
3.0
Inclusion and Exclusion Criteria* ............................................................................5
4.0
Study-Wide Number of Subjects*............................................................................5
5.0
Study-Wide Recruitment Methods* .........................................................................5
6.0
Multi-Site Research* ................................................................................................5
7.0
Study Timelines*......................................................................................................5
8.0
Study Endpoints*......................................................................................................5
9.0
Procedures Involved* ...............................................................................................6
10.0
Data and Specimen Banking*...................................................................................7
11.0
Data Management* and Confidentiality...................................................................7
12.0
Provisions to Monitor the Data to Ensure the Safety of Subjects*...........................7
13.0
Withdrawal of Subjects*...........................................................................................8
14.0
Risks to Subjects*.....................................................................................................8
15.0
Potential Benefits to Subjects* .................................................................................8
16.0
Vulnerable Populations*...........................................................................................9
17.0
Community-Based Participatory Research*.............................................................9
18.0
Sharing of Results with Subjects* ............................................................................9
19.0
Setting.......................................................................................................................9
20.0
Resources Available .................................................................................................9
21.0
Prior Approvals.......................................................................................................10
22.0
Recruitment Methods..............................................................................................10
23.0
Local Number of Subjects ......................................................................................10
24.0
Provisions to Protect the Privacy Interests of Subjects ..........................................10
25.0
Compensation for Research-Related Injury............................................................10
26.0
Economic Burden to Subjects.................................................................................10
27.0
Consent Process......................................................................................................10
28.0
Process to Document Consent in Writing...............................................................11
29.0
Drugs or Devices ....................................................................................................11

Compass Device Trial
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1.0
Objectives*
1.1
This is a single-arm observational trial of a new FDA-approved 
device (Compass Vascular Access device, Centurion Medical 
Products, Williamston MI; formerly Mirador Boimedical).  This 
device is a compact, sterile, single-use extravascular blood pressure 
transducer with a continuous digital pressure display.  This pressure 
measurement provides an aid in the confirmation of appropriate 
venous access.  The device has FDA 510(k) clearance as 
substantially equivalent to existing devices on the market.  Evidence 
of this clearance is included with this application.
1.2
The investigators plan to enroll 40 consenting patients with BMI ≥35 
who require central venous catheterization for clinical reasons 
independent of the existence of this study.  For purposes of the 
study, the investigators will record data germane to the procedure as 
well as operator satisfaction.  Analysis of these data will be used to 
evaluate the appropriateness of the device for this procedure in the 
obese population, where device ergonomics may be more of a factor 
than in previous studies.
1.3
This study is not investigating the safety of the device, because the 
primary outcome is operator satisfaction.  None of the observed 
outcomes relate directly to device safety, and the study is not 
powered to detect rare adverse events.
1.4
This study is also not investigating the effectiveness of the device.  
The investigators are not gathering any data that would permit 
evaluation of the device’s accuracy or precision, which are the 
salient factors for effectiveness of a measurement device.
1.5
Deidentified study data may be shared with the sponsor, but the 
investigators do not plan to submit study data to the FDA.
2.0
Background*
Central venous catheterization (CVC) is a common perioperative procedure that is 
associated with a number of potential mechanical complications.   It involves three steps: 
first a needle is introduced to the target vein, followed by a guidewire, and finally the 
catheter itself.  The needle is relatively fine, and the guidewire slightly larger, but the 
catheter is relatively large, with corresponding increases in the severity of complications 
associated with arterial puncture.  Inadvertent arterial cannulation is the most common 
mechanical complication of CVC placement and is associated with significant morbidity 
and mortality.(1)  Complications of arterial puncture or cannulation may lead to 
uncontrolled hemorrhage, airway compromise related to neck hematoma, cerebrovascular 
accident, hemothorax, mediastinal bleeding, cardiac tamponade, aortic dissection, and 
death.
The use of ultrasound guidance for CVC has mitigated the risk for arterial 
cannulation but not eliminated it.  Ultrasound guidance has decreased the rate of arterial 
puncture to rates as low as 0.5%.(1)  Nonetheless, arterial cannulation can still occur 
during CVC placement with ultrasound guidance for a variety of reasons primarily 

Compass Device Trial
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related to either incorrect identification of the target vein or the inability to accurately 
determine the location of the tip of the access needle.(2)
Due to the limitations of two-dimensional surface ultrasound and the goal of 
further mitigating the risk of arterial access during CVC insertion, various methods have 
been employed to confirm that only the target vein has been accessed.  One method is 
echocardiographic confirmation of guidewire placement in the superior vena cava and/or 
the right heart; however, aside from select operative procedures, use of echocardiography 
in the perioperative period or in the intensive care unit (ICU) is limited, costly, and may 
not be contemporaneous with CVC placement.  A second method is the use of column 
manometry to transduce the intravascular pressure.  However, performance of manometry 
may be cumbersome and may generate a false negative finding (fluid column appears 
venous) even when the CVC is intra-arterial due to obstruction of the proximal 
transduction site or a low cardiac output state.
An FDA-approved electronic extravascular blood pressure monitor (Compass® 
Vascular Access device, Centurion Medical Products, Williamston, Mi.) has been 
recently developed which provides an aid in the confirmation of appropriate CVC access.  
The device is a compact, sterile, single-use pressure transducer that has a continuous 
digital pressure (mmHg) display.  The device connects in a luer-lock fashion to all 
standard syringes and needles and has a separate self-sealing channel for CVC guidewire 
insertion and withdrawal.  The device is intercalated between the syringe proper and the 
needle used to access the target vessel.  The device permits confirmation of guidewire 
insertion into the target vein via its pressure display.  There are two previous reports on 
the use of this device in the perioperative and ICU settings.(3,4)  In the report by Togashi 
et al(3), 298 CVC placements were performed with the device and five inadvertent 
arterial punctures occurred even though ultrasound guidance was utilized.  All five of 
these inadvertent arterial punctures were correctly identified prior to cannulation because 
of the use of the device.(3)  The device did not produce any adverse events.  Furthermore, 
Togashi et al performed a cost-benefit analysis comparing the claim costs associated with 
a single mechanical CVC injury (per American Society of Anesthesiology Closed Claims 
Database(5): $95,000 / event) versus device costs and found that the use of the novel 
device generated a net savings of $116 for each CVC insertion.(3)  The Togashi group (3) 
noted that some operators would prefer a smaller device, but most were satisfied with it 
as tested.  The planned case series is intended to evaluate use of the device in the obese 
population (BMI ≥ 35 kg/m2), where device ergonomics may be more of a factor.
References:
1.
Fragou M, Gravvanis A, Dimitriou V, Papalois A, Kouraklis G, Karabinis A, 
Saranteas T, Poularas J, Papanikolaou J, Davlouros P, Labropoulos N, Karakitsos D. 
Real-time ultrasound-guided subclavian vein cannulation versus the landmark method in 
critical care patients: a prospective randomized study. Crit Care Med 2011;39:1607-12.
2.
Reusz G, Csomos A. The role of ultrasound guidance for vascular access. Curr 
Opin Anaesthesiol 2015;28:710-6.
3.
Togashi K, Nandate K, Hoaglan C, Sherman B, Bowdle A. A multicenter 
evaluation of a compact, sterile, single-use pressure transducer for central venous catheter 
placement. Anesth Analg 2013;116:1018-23.

Compass Device Trial
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4.
Visweswaran GK, Lightfoot J, Gilchrist IC. Novel use of a disposable digital 
pressure transducer to increase the safety of pericardiocentesis. Catheter Cardio Inte 
2013;81:E68-E71.
5.
Domino KB, Bowdle TA, Posner KL, Spitellie PH, Lee LA, Cheney FW. Injuries 
and liability related to central vascular catheters: a closed claims analysis. Anesthesiology 
2004;100:1411-8.
3.0
Inclusion and Exclusion Criteria*
3.1
The study population consists of obese (≥35 kg/m2) adult (≥18 yrs) 
patients presenting at the UNM Hospital main/adult operating rooms 
who require central venous catheter (CVC) placement for their 
perioperative care.  The investigators will exclude pregnant women, 
adults unable to consent, and prisoners.
3.2
Members of the commonly recognized vulnerable populations will 
not be enrolled: pregnant women, prisoners, neonates of uncertain 
viability or that are nonviable, and minors.
4.0
Study-Wide Number of Subjects*
4.1
The planned completed sample size is 40 patients.  The investigators 
request HRRC permission to enroll up to 45 patients in order to 
accommodate any whose CVC procedures may be cancelled 
between consenting and commencement of the actual procedure, but 
will only complete data collection for 40 patients.
5.0
Study-Wide Recruitment Methods*
This is a single-site study; local recruitment methods are described in section 22 
below.
6.0
Multi-Site Research*
6.1
This is a single-site study.
7.0
Study Timelines*
7.1
Describe:

A given individual will participate in the study for 
approximately 15 minutes, representing the time required for 
the CVC placement.

The investigators anticipate that the study sample can be 
enrolled in approximately six months to one year.

The investigators estimate that all analyses will be completed 
in one year after completion of enrollment.
8.0
Study Endpoints*
8.1
This is an observational study.  The main data point of interest is 
operator satisfaction.  The number of inadvertent arterial punctures 

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identified by the device (if any) will also be recorded.  The data 
collection form is included with this HRRC application.
8.2
The investigators have not identified any safety endpoints.
9.0
Procedures Involved*
9.1
This is an observational study to be completed on 40 patients 
meeting the inclusion/exclusion criteria.  Subjects presenting for 
CVC placement at the UNMH operating suites will be prepared as 
usual and consent obtained.  The Compass pressure measurement 
device will be included in the CVC placement apparatus as per the 
manufacturer’s directions.  Data will be recorded on the placement 
procedure as well as routine patient demographic data.  Identifiers 
will not be recorded.
9.2
A photograph of the device (with attached syringe and needle) is 
below.  
9.3
The only research procedure is the inclusion of the device in the 
CVC placement apparatus, for patients who would already be having 
CVC placement regardless of the existence of this study.  The 
research does not modify routine practice surrounding CVC 
placement (patient selection and preparation, operating personnel, 
catheter equipment, the procedure itself, or medications used) in any 
way.  These considerations should mitigate risks.
9.4

As noted above, enrollment of subjects from a population 
already presenting for CVC placement regardless of the 
existence of this study mitigates study risks.  The investigators 
are similarly not modifying routine CVC practice except to 
specify the use of the studied device.

The project does not specify the use of any drugs.  The device 
being studied is the Compass for CVC pressure transducer 
device (Centurion Medical Products, Williamston MI).

The data collection form is included with this application.

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9.5
Data to be collected include routine demographic data (age, sex, 
height, weight, BMI, ASA status), data surrounding the CVC 
placement procedure (insertion location, use of ultrasound guidance, 
venous pressure before/after guidewire placement, operator 
satisfaction), and incidence of inadvertent arterial puncture.
10.0
Data and Specimen Banking*
10.1 Data will be recorded on paper forms with identifiers in order to 
permit resolution of any incomplete/unclear data entries.  Data will 
be deidentified upon transfer to an electronic spreadsheet for 
analysis.  The identifiable data forms will be retained until 
publication of results in order to permit any supplemental analyses 
requested by peer reviewers.  The deidentified data may be retained 
indefinitely for potential future use, such as in serving as the 
underlying dataset for power analysis of a future study.
10.2 Deidentified data may be reviewed by the study sponsor.  Release of 
deidentified data may be requested by contacting the PI and/or 
sponsor.  Both the PI and study sponsor must approve release. 
Release will only be made to personnel who are qualified researchers 
pursuing legitimate research projects, in the opinion of the PI and/or 
sponsor.  Identifiable data will not be released except as required by 
law.
11.0
Data Management* and Confidentiality
11.1 Data will be summarized by reporting mean (SD) of continuous 
variables such as BMI and age, percentages for categorical data such 
as patient sex, and raw count for inadvertent arterial punctures.
11.2 As this is an observational study, a power analysis is not useful.
11.3 All investigators are CITI- and HIPAA-certified.  Completed data 
collection forms will be maintained in locked cabinets in 
Anesthesiology department offices, which are a patient-restricted 
area.  As noted in section 10 above, the deidentified data will be 
retained indefinitely.  Only investigators will have access to study 
data, but they will transmit an electronic copy of deidentified study 
data to the sponsor upon request.  Qualified researchers may request 
an electronic copy of the deidentified data as listed in section 10 
above.  Identifiable data will not be released except as required by 
law.
12.0
Provisions to Monitor the Data to Ensure the Safety of Subjects*
The investigators believe that this is a Minimal Risk study.  The only 
research-related procedure is the inclusion of a small FDA-approved 
device in the apparatus used to perform CVC placement, in accordance 
with its labeling.

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13.0
Withdrawal of Subjects*
13.1 The investigators have not identified any circumstances in which 
participants would be withdrawn without their consent.
13.2 The investigators do not anticipate situations in which advance plans 
for orderly termination of research participation would be required.
13.3 The investigators do not anticipate any requests for withdrawal from 
the study.
14.0
Risks to Subjects*
14.1 Previous studies on this sterile, single-use device have identified no 
adverse events arising due to its use.  The only issue identified to 
date is the size of the device; a few operators (reported in reference 3 
listed above) would prefer that it be smaller.  It is therefore possible, 
but has not ever been demonstrated, that the device’s presence may 
impede CVC placement in some way.  This risk is completely 
reversible, because the device can simply be removed from the 
needle apparatus if it is in the way.  As in any study, there are risks 
of confidentiality breach.  This study does not gather data that are 
especially sensitive, so the consequences of any confidentiality 
breach are minor.  All risks are mitigated to the extent possible by 
restricting enrollment to a population that would have received CVC 
placement regardless of the existence of this study.
14.2 The presence of the device in the needle apparatus may present some 
unforeseeable risk, but as noted above, no such risks have been 
reported, and the device can simply be removed so that the CVC 
placement can proceed as usual.
14.3 The investigators have not identified any risks to the embryo or fetus 
should a subject be pregnant at the time of the study.
14.4 The investigators have not identified any risks to others who are not 
subjects.
15.0
Potential Benefits to Subjects*
15.1 While rare, inadvertent arterial puncture is possible during CVC 
placement.  The studied device does not eliminate this risk, but 
rather permits early identification of arterial placement through 
pressure measurement; pulsatile pressure indicates arterial 
placement.  Identification of arterial puncture at this point, before 
introduction of the guidewire or catheter, greatly reduces the 
consequences of arterial puncture.  In a previous study on this device 
(reference 3 above), arterial puncture was identified in 1.7% of 
subjects, and all were recognized before guidewire insertion (and 
thus clearly before catheter insertion; no guidewires or catheters 
were inserted in arteries).  Subjects in this study may similarly 

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receive the benefit of early identification of inadvertent arterial 
puncture, if any of these punctures do occur.
16.0
Vulnerable Populations*
16.1 This project does not involve the commonly-recognized vulnerable 
populations.
17.0
Community-Based Participatory Research*
This study does not constitute community-based participatory 
research.
18.0
Sharing of Results with Subjects*
18.1 This study does not involve testing or other results that may affect 
future treatment decisions for subjects, so there are none to share 
with subjects.  Final study results will also not be shared with 
patients, because others’ experience has no direct effect on the 
patient.  
19.0
Setting
19.1 Research activities will occur at the UNMH operating suites and in 
the Anesthesiology department offices.

Subjects will be identified from among the patient population 
at the UNMH operating suites.  CVC placement for recruited 
patients will occur as planned at the UNMH main operative 
setting.
20.0
Resources Available
20.1 All investigators who will perform the CVC placements are licensed 
physicians authorized to practice and perform this procedure at 
UNMH.  Investigator Tim Petersen PhD is a staff member in the 
Department of Anesthesiology with experience in study design and 
data analysis.
20.2 Describe other resources available to conduct the research: For 
example, as appropriate:

A conservative estimate of the number of patients presenting to 
the UNMH main OR suites who require CVC placement is 10-
20 per week.  Of these, approximately 1/3 have BMI ≥35.

Investigators will conduct study activities in conjunction with 
their routine clinical and non-clinical duties. 

The operating suites at UNMH are equipped with the 
personnel, facilities, and other resources needed to place CVCs 
and respond to any eventuality arising from the placement of a 
CVC.

Upon HRRC approval, the approved version of the protocol 
will be distributed to all participating investigators.  The 

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investigators do not anticipate any need for protocol 
modifications after HRRC approval.
21.0
Prior Approvals
21.1 Beyond the routine departmental review process and HRRC review, 
no other approvals are necessary for this project.
22.0
Recruitment Methods
22.1 After HRRC approval, enrollment will occur among at least 40 and 
up to 45 patients meeting the inclusion/exclusion criteria.
22.2 Subjects will be drawn from adult patients requiring CVC placement 
at the UNMH main operating rooms.
22.3 Investigators will identify subjects from among their routine patients.  
22.4 No patient recruitment materials will be used.
22.5 Subjects will not be paid.
22.6 Investigators have drafted a proposed information handout for 
participating physicians who will place CVCs with the Compass 
device in this study.  The handout notes that an investigator will 
obtain patient consent, and outlines both the target population and 
the study procedures.  It also encourages participating physicians to 
contact the PI with any remaining questions.
23.0
Local Number of Subjects
23.1 As noted above, up to 45 patients will be included in this study, with 
a target completed sample size of 40.
24.0
Provisions to Protect the Privacy Interests of Subjects
24.1 All research-related activity will occur in the context of medical 
care, which already occurs in a suitable private location.  Similarly, 
investigators are already authorized to initiate contact with potential 
subjects as part of clinical care.
25.0
Compensation for Research-Related Injury
25.1 The investigators believe that this is a Minimal Risk study.  As such, 
there is not a plan for compensation for research-related injury.
26.0
Economic Burden to Subjects
26.1 Participation will not modify patient costs in any way.
27.0
Consent Process
27.1.
Consent will be obtained by an HRRC-approved investigator prior to the 
commencement of research procedures.  All investigators are CITI- and HIPAA-
certified.
27.1.1. The consent process will occur in the UNMH operating suites.

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27.1.2. Coercion and undue influence will be avoided by not paying participants, 
and by assuring prospective enrollees that their participation is entirely 
voluntary: they can still receive CVC placement without participating.
27.1.3. Additional lead time for prospective subjects to consider participation is 
not available in this study because CVC placement is usually performed 
shortly after the decision that one is needed.  Similarly, there is published 
research that examines the effect of additional consideration time on 
patients’ views of the consent process and their rights in anesthesia 
clinical trials.  This research has shown that consent on the day of surgery 
for trials of treatments with similar risks/benefits does not compromise 
patient rights or welfare. The study authors (Murphy et al., “Consent for 
Anesthesia Clinical Trials on the Day of Surgery,” Anesthesiology 2016; 
124:1246-55) found that anesthesia patients approached for research 
consent on the day of surgery were satisfied with the consent process, 
felt that the protocol was well explained and comprehended, and agreed 
that the setting was appropriate.  Conversely, these patients strongly 
disagreed that they were anxious at the time of consent, felt any obligation 
to participate, or regretted participating.  Importantly, these results were 
not changed by the use of a preadmission telephone call to describe the 
research protocol and provide greatly extended time for patients to 
consider their participation.  If patients felt that day-of-surgery consent 
represented a violation of their rights or an imposition on their welfare, 
these results would have been very different.
27.1.4. As this study involves a one-time clinical procedure, the investigators 
believe that a one-time consent procedure is appropriate, and the study 
thus does not require provisions for ensuring ongoing consent.
Subjects not fluent in English
27.1.5. As this study involves a relatively small sample, the investigators 
anticipate that few subjects will speak Spanish exclusively.  If any eligible 
patients are Spanish speakers, the investigators will use the routine 
UNMH oral translation procedures to obtain consent, document it with the 
Spanish short form consent included with this application, and provide 
subjects with a copy of the English consent document as well.
Cognitively Impaired Adults/Adults Unable to Consent/Use of a Legally 
Authorized Representative
27.1.6. Inability to consent is an exclusion criterion.
Subjects who are not yet adults (infants, children, teenagers)
27.1.7. Only adults will be enrolled.
28.0
Process to Document Consent in Writing
28.1 Consent will be documented on an HRRC-approved consent form; a 
proposed form is included with this application.

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29.0
Drugs or Devices
29.1 The devices to be studied will be stored in the Cardiac Anesthesia 
office, which is a separate area within the patient-restricted 
Department of Anesthesiology administrative offices.  These offices 
are adjacent to the UNMH operating suites, so obtaining a device for 
a relevant patient will not present significant delay to any 
procedures.  In this way, the devices will be maintained separately 
from regular operating room supplies and equipment, so they will 
not be mistakenly used on non-subject patients.  
29.2 Device trade name: Compass for CVC
29.3 Device common name: Extravascular blood pressure transducer
29.4 Manufacturer: Centurion Medical Products, Williamston MI 
(formerly Mirador Biomedical)
29.5 The device received FDA 510(k) clearance (K133624) without a 
requirement for clinical testing, and there is not an IDE for this study 
(see section 29.7 below).
29.6 The use of the device in this setting does not present a potential for 
serious risk to the health, safety, or welfare of a subject.
29.7 This study is IDE-exempt in accordance with 21 CFR 812.2(c) and 
the FDA’s “Information Sheet Guidance for IRBs, Clinical 
Investigators, and Sponsors: Frequently Asked Questions about 
Medical Devices” available at 
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/U
CM127067.pdf (see section 12C on page 8 of that document), 
because the device will be used in accordance with the indications in 
its approved labeling in this study.  The study does not modify the 
labeling, indications, instructions for use, or any other aspect of 
device administration.  The study reviews operator satisfaction when 
using the device as directed in one subset of the intended population.