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Anesthesia & Analgesia:
doi: 10.1213/ANE.0b013e31828a6e53
Technology, Computing, and Simulation: Technical Communication

A Multicenter Evaluation of a Compact, Sterile, Single-Use Pressure Transducer for Central Venous Catheter Placement

Togashi, Kei MD*; Nandate, Koichiro MD, PhD*; Hoaglan, Carli MD; Sherman, Benjamin MD; Bowdle, Andrew MD, PhD*

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From the *Department of Anesthesiology, University of Washington; Department of Anesthesiology, Virginia Mason Medical Center, Seattle, Washington; and Department of Anesthesiology, Yale University, New Haven, Connecticut.

Accepted for publication January 08, 2013

Published ahead of print March 14, 2013

Funding: None. Compass device was provided without cost to Virginia Mason Medical Center and Yale University. The device was purchased at University of Washington. This was based on institutional preference. There were no publishing agreements with Mirador Biomedical.

See Disclosures at end of article for Author Conflicts of Interest.

Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Web site (www.anesthesia-analgesia.org).

Reprints will not be available from the authors.

Address correspondence to Kei Togashi, MD, Department of Anesthesiology, University of Washington, Mail Stop 356540, Seattle, WA 98195. Address e-mail to ktogashi@u.washington.edu.

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Abstract

BACKGROUND: Inadvertent arterial placement of a large-bore catheter during attempted placement of a central venous catheter (CVC) occurs at a rate of 0.1% to 1.0% and may result in hemorrhage, pseudoaneurysm, stroke, or death. Ultrasound guidance or observation of color and pulsatility of blood are not reliable methods for avoiding this serious complication. Measurement of pressure in the needle or short plastic catheter before insertion of the guidewire has been shown to be highly reliable; however, traditional pressure measurement methodology is cumbersome. Recently a compact, sterile, single-use pressure transducer with an integrated digital display has become available. In this study, we evaluated the performance of this new device (Compass® Vascular Access).

METHODS: In this prospective, observational study at 4 academic medical centers 298 CVCs were placed. Pressure was measured using the Compass transducer before and after guidewire insertion. Other details of the procedure were at the discretion of the clinician. Data describing the CVC placement and any complications were collected.

RESULTS: Trainees placed 279 of 298 CVCs. Ultrasound guidance was used for 286 of 298 CVCs. Seven of the CVC placements occurred in the intensive care unit, with the balance occurring in the operating room. Ten of the CVCs were placed in a subclavian vein, with the balance being internal jugular vein. Two hundred seventy-four of 298 CVCs were placed on the right side. Venous pressure measured before and after guidewire insertion was 7.2 ± 4.3 (SD) and 6.5 ± 4.3 (SD) mm Hg respectively (P = 0.03). The satisfaction score recorded by the physician performing the procedure was 8.0 ± 2.1 (SD; visual analog scale 1–10, 10 being most satisfying). There were 5 inadvertent arterial punctures (1.7%). Ultrasound guidance was used in all 5 cases of arterial puncture. All of the arterial punctures were recognized before guidewire insertion by measurement of arterial pressure with the Compass transducer. No guidewires or CVC catheters were placed in arteries.

CONCLUSION: The Compass pressure transducer for CVC placement performed as intended in 298 cases from 4 academic medical centers. There were 5 inadvertent arterial punctures despite the use of ultrasound guidance, all of which were correctly identified by pressure measurement using the Compass. The device was easily used by trainees, and users expressed a positive level of satisfaction.

Central venous catheter (CVC) placement is associated with significant morbidity and mortality.1,2 Although much recent attention has been focused on the risk of infection,3 mechanical complications such as inadvertent arterial cannulation form a substantial portion of the serious adverse outcomes.4 Inadvertent arterial puncture with a small needle during CVC placement ranges from 4.2% to 9.3% in reported series.5–8 Many of these small needle punctures are recognized, but some are not. Failure to recognize these arterial punctures has resulted in subsequent placement of a large-bore catheter (>7 Fr) into an artery, ranging from 0.1% to 1.0% of attempted CVC placement in reported series.9–13 Inadvertent arterial placement of a large-bore catheter may result in hemorrhage, pseudoaneurysm,14 stroke, or death.15,16 The traditional method for avoiding arterial placement is to observe the color and pulsatility of blood in the needle hub before placement of the guidewire. However, this approach has been shown to be unreliable.5–7,17 By contrast, measurement of pressure in the needle is a highly reliable method for distinguishing artery from vein.5–7 Ezaru et al.5 and Jobes et al.6 found that relying only on color and pulsatility missed 14% to 20% of instances of arterial puncture (i.e., false negative rate), which were only discovered by manometry. Traditional methods for pressure measurement include column manometry (sterile tubing attached to the needle and allowed to backfill with blood) or the use of a pressure transducer, connected to the hub of the needle by a length of sterile pressure tubing with the results displayed on a monitor.18

Recently published guidelines recommend the use of ultrasound during CVC placement.19–21 However, the tip of the needle must be clearly visualized in the vein to assure venous placement of the guidewire. Troianos et al.17 found that ultrasound guidance reduced the incidence of arterial puncture from 8.4% to 1.4% during attempted internal jugular vein cannulation. By contrast, Hameeteman et al.8 reported the incidence of arterial puncture to be 7.8% during attempted internal jugular CVC placement with ultrasound guidance by surgical trainees. There are numerous reports of inadvertent arterial placement of large-bore catheters that have occurred despite the use of ultrasound guidance.22–26 Ultrasound guidance may be of limited use with the subclavian approach.27

Ultrasound guidance and pressure measurement during CVC placement have had limited acceptance despite evidence that their use can prevent central line complications.28,29 In part, this can be explained by operator difficulty with executing the techniques combined with a lack of readily available tools. These considerations led to the development of the Compass® Vascular Access device (Mirador Biomedical, Seattle, WA; Fig. 1). This compact, sterile, single-use pressure transducer with integrated digital display connects to standard needles and syringes, allowing continuous measurement of the intravascular pressure and a representation of the pressure waveform during central line placement without adding additional steps to the procedure. The compact, self-contained design may overcome some of the technical challenges that have limited adoption of other pressure-measuring techniques. Notably, the device has a self-sealing guidewire port that allows for continuous pressure measurement during guidewire insertion, allowing for confirmation that the wire has been inserted into a vein rather than an artery; this is important because the needle used to introduce the guidewire into the vein can be inadvertently moved into an artery after a venous pressure has been measured in the needle hub.30

Figure 1
Figure 1
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The Compass device received Food and Drug Administration 510(k) clearance without a requirement for clinical testing. There is only 1 previous report on the clinical use of this device.31 The purpose of this study was to conduct an initial clinical evaluation of the performance of the device during CVC insertion in the operating room and intensive care unit.

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METHODS

We conducted a multicenter observational study at 4 hospitals with anesthesiology residency training programs, University of Washington Medical Center (Seattle, WA), Harborview Medical Center (Seattle, WA), Virginia Mason Medical Center (Seattle, WA), and Veterans Affairs Connecticut Medical Center (Yale University Affiliate; West Haven, CT), from March 2011 to March 2012. The study was approved by each institution’s IRB. The requirement for written informed consent was waived by the IRB. We collected data on 298 consecutive procedures. These procedures were performed on cardiothoracic surgery patients at the University of Washington Medical Center, and on general surgery patients at the other institutions. These procedures were performed only by investigators participating in the IRB-approved study and constituted <50% of the total number of CVC placements at each institution.a Almost all central venous insertions were performed using an 18-gauge metal needle; a few cases were performed using a short plastic catheter over a metal needle.

Sterile, single-use Compass pressure transducers were obtained from Mirador Biomedicalb at no cost to Virginia Mason Medical Center and Veterans Affairs Connecticut Medical Center. The device was purchased by University of Washington Medical Center and Harborview Medical Center. The accuracy of the device was tested by the manufacturer to be within ±2 mm Hg below 50 mm Hg. Pressure accuracy testing was performed in compliance with the standard ANSI/AAMI BP22 (Blood Pressure Transducers). Compass pressure readings over the range −199 mm Hg to +199 mm Hg were compared with a calibrated and standardized electronic manometer. The device also has an incorporated safety function; each time a device is turned on, it performs extensive self-checks to verify proper operation and accuracy, including checking remaining battery life, firmware and memory integrity, pressure sensor operation, calibrating to the current ambient pressure, and verifying that the unit is operating within the specified temperature range. A failure of any of these self-checks will result in the unit being locked in a nonoperational state with the appropriate error code flashing on the screen.

The Compass pressure transducer is connected between the needle and the syringe before attempting venous access. Then, a multifunction switch is depressed activating the device, which self-calibrates to atmospheric pressure. Aside from the use of the Compass transducer, other details of the procedure were left to the discretion of the operators, including the optional use of ultrasound guidance. Either an 18-gauge metal needle or a plastic over metal needle was used for blood aspiration. After blood aspiration, the pressure displayed on the screen of the Compass was noted and recorded. There was no negative or positive pressure applied to the syringe plunger during measurement. After confirmation of venous pressure, a guidewire was inserted through the self-sealing guidewire port. The pressure was again noted and recorded. After confirmation of venous pressure at the site of guidewire insertion, the needle, Compass, and syringe were removed as a unit leaving only the guidewire in place, and a CVC or introducer sheath was placed over the guidewire using the Seldinger technique.

Some operators prefer to insert a short plastic catheter into the vein before guidewire insertion rather than use a metal needle. In this case, the Compass was placed between the syringe and short plastic catheter over needle. After puncture of the vein and identification of a venous pressure on the display screen, the plastic IV catheter was advanced over the needle into the vein. The syringe, Compass, and needle were removed as a unit, and the syringe and Compass were reattached to the short plastic catheter. After again identifying a venous pressure on the display screen, the guidewire was inserted through the self-sealing guidewire port. The syringe, Compass, and short plastic catheter were removed as a unit, leaving only the guidewire in place and the CVC or introducer sheath was placed over the guidewire using the Seldinger technique.

Data collected included the type of CVC kit used, insertion site, clinical setting, training level of the operator (when the operator was a trainee, the procedure was supervised by an attending anesthesiologist), patient characteristics, usage of ultrasound guidance, pressure measured with the Compass transducer (before and after guidewire insertion), operator satisfaction score on a visual analog scale, number of needle insertions required for successful venous access, occurrence of inadvertent arterial punctures, and the method by which the arterial puncture was identified, and any complications. The data collection sheet is shown in Appendix 1 (see Supplemental Digital Content 1, http://links.lww.com/AA/A533).

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Statistical Analysis

Continuous, discrete, and categorical data were described as the mean and SD. The Mann-Whitney test was used for comparison of pressure before and after guidewire placement. P < 0.05 was considered statistically significant. There were no multiple comparisons, and the P-value was not adjusted. All statistical comparisons were performed using STATA version 11.0 (Statacorp, College Station, TX).

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RESULTS

Patient characteristics are described in Table 1. A total of 298 CVC placements were performed during the 12-month study period as shown in Table 2. Large-bore catheters used during these procedures included 7 Fr double-lumen and triple-lumen catheters, and 8.5 and 9 Fr introducer sheaths for pulmonary artery catheterization (all central line kits were manufactured by Arrow International Inc., Reading, PA). Other results are shown in Table 2. The satisfaction scores recorded by the physicians performing the procedure averaged 8.0 ± 2.1 (SD; scale of 1–10, 10 being most satisfied). There were 5 inadvertent arterial punctures (1.7%). Ultrasound guidance was used in all 5 cases of arterial puncture. All of the arterial punctures were recognized before guidewire insertion by measurement of arterial pressure and pulsatility with the Compass transducer (2 were also confirmed by color). No guidewires or CVC catheters were placed in arteries.

Table 1
Table 1
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Table 2
Table 2
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DISCUSSION

In this study of 298 CVC placements, we conducted an initial clinical evaluation of the performance of the Compass pressure transducer during CVC insertion in the operating room and intensive care unit. Measurement of pressure in the needle before guidewire insertion is a method for avoiding inadvertent arterial cannulation that has been shown to be effective in several studies.5–7 However, many operators find the traditional techniques for measuring pressure (column manometry and standard pressure transduction with sterile pressure tubing connected to a nonsterile transducer) cumbersome. In addition, the traditional methods do not allow measurement of pressure during insertion of the guidewire.

The sterile single-use Compass pressure transducer is a compact, convenient method for measuring pressure during needle insertion. Previously described methods for continuous pressure measurement used stopcocks7 or T-shaped adaptors18 for connection of a conventional transducer to a needle. However, the Compass, unlike these pressure measurement techniques, also allows for measurement of pressure during insertion of the guidewire through a self-sealing port. Pressures recorded with the guidewire in place were slightly (<1 mm Hg on average) lower than the pressures measured from the needle, probably because of the slight resistance imposed by the guidewire, which can transiently reduce the pressure. In our experience, we found that immediately after insertion of the guidewire the pressure was sometimes close to zero but returned to a pressure near the baseline pressure after a few seconds. Pressure equilibration after guidewire insertion will occur more quickly if the operator pulls the wire back a few millimeters after insertion. Presumably, this is because pulling the wire back a few millimeters draws some blood into the guidewire port channel, providing a continuous fluid pathway for pressure measurement.

The 5 inadvertent arterial punctures with an 18-gauge needle that occurred despite the use of ultrasound were recognized before guidewire insertion. This finding confirms previous reports showing that ultrasound guidance may reduce the frequency of inadvertent arterial punctures but cannot be relied on to identify every arterial puncture.22–26

During all but 19 applications of the Compass in this study, the operator was an anesthesiology resident. In many cases, the resident encountered the Compass for the first time. Despite this, the residents were able to use the device effectively.

Operators indicated an overall positive level of user satisfaction, as shown by a mean satisfaction score of 8.0 on a visual analog scale where 1 is completely unsatisfied, 5 is neutral, and 10 is completely satisfied. The main request from some operators was for a more compact device, although most operators were satisfied by the size of the device as tested.

Cost-effectiveness is often an issue with new medical devices. Inadvertent arterial cannulation is expensive because it typically results in either a surgical or interventional radiology procedure to remove the catheter safely.11,16,24,32–38 Using a blind “pull-pressure” technique to remove catheters has been shown to result in a 47% chance of serious complications and a 12% chance of death,16 the costs of which may far exceed the safer surgical or interventional radiology approach. In addition, litigation may result in medical–legal costs. The average claim for a mechanical injury associated with CVC placement was approximately $95,000 in a review of claims from the American Society of Anesthesiologists Closed Claims Database (not including any legal expenses).4 We performed a cost–benefit analysis (Appendix 2, see Supplemental Digital Content 2, http://links.lww.com/AA/A534) assuming an inadvertent arterial cannulation rate of 0.5% without pressure measurement, a rate of 0% with pressure measurement, and a cost of $35 for the Compass device. This is a deterministic analysis, which does not consider parameter or structural uncertainty. After weighing the costs related to endovascular repair and possible medical–legal claims (not including legal expenses), there would be a net savings of $116 per CVC placement using the Compass for pressure measurement.

Although our cost-effectiveness analysis suggests that the Compass could actually save money by preventing complications, there is another possible approach that would be less expensive than the Compass. Hypothetically, if the operator inserts a short plastic catheter into the vein and then measures a pressure using tube manometry, the safety goals of the Compass should be accomplished at a lower cost. However, the use of a metal needle and tube manometry rather than a short plastic catheter and tube manometry would not be an equivalent safety approach to the Compass. This is because of the possibility that the metal needle can be inadvertently moved into an artery after pressure measurement, possibly resulting in placement of a large-bore catheter into an artery. The latter result is unlikely to occur with the use of a short plastic catheter or if the guidewire is inserted through the metal needle using the Compass guidewire port and the pressure is then measured. The main drawback of the approach using a short plastic catheter and tube manometry is that the hub of the short plastic catheter has to be opened to connect the tube manometer, and then reopened for guidewire insertion; when a metal needle is used with the Compass, the system remains closed throughout the procedure, without any need to disconnect and reconnect anything to the hub of the needle. The choice between the use of a short plastic catheter and tube manometry and the use of the Compass (with either a metal needle or a short plastic catheter) is ultimately a matter of the comfort level and style of the individual operator; from a safety standpoint, these 2 methods would be expected to give comparable results.

An important limitation of this study is that we did not encounter patients with extremely elevated central venous pressure and low systemic blood pressure as may be seen in cardiogenic shock. Under these circumstances, it might be difficult to distinguish central venous pressure from systemic blood pressure. But this may limit other pressure-measuring methods as well and does not pertain to our study only. Another limitation is sample size. There were only a small number of arterial punctures. However, it was not the primary purpose of this study to establish the effectiveness of pressure monitoring.

In summary, the compact, sterile, single-use Compass pressure transducer for CVC placement performed as intended in 298 cases from 4 academic medical centers. There were 5 inadvertent arterial punctures despite the use of ultrasound guidance, all of which were correctly identified by pressure measurement using the Compass. The device was easily used by trainees, and overall operator satisfaction was positive.

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DISCLOSURES

Name: Kei Togashi, MD.

Contribution: This author helped design and conduct the study, collect the data, analyze the data, and prepare the manuscript.

Attestation: Kei Togashi approved the final manuscript. Kei Togashi attests to the integrity of the original data and the analysis reported in this manuscript. Kei Togashi is the archival author.

Conflicts of Interest: The author has no conflicts of interest to declare.

Name: Koichiro Nandate, MD, PhD.

Contribution: This author helped collect the data.

Attestation: Koichiro Nandate approved the final manuscript.

Conflicts of Interest: The author has no conflicts of interest to declare.

Name: Carli Hoaglan, MD.

Contribution: This author helped collect the data.

Attestation: Carli Hoaglan approved the final manuscript.

Conflicts of Interest: The author has no conflicts of interest to declare.

Name: Benjamin Sherman, MD.

Contribution: This author helped collect the data.

Attestation: Benjamin Sherman approved the final manuscript.

Conflicts of Interest: The author has no conflicts of interest to declare.

Name: Andrew Bowdle, MD, PhD.

Contribution: This author helped design the study and prepare the manuscript.

Attestation: Andrew Bowdle approved the final manuscript.

Conflicts of Interest: Andrew Bowdle is a scientific advisor to Mirador Biomedical.

This manuscript was handled by: Dwayne R. Westenskow, PhD.

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ACKNOWLEDGMENTS

The authors acknowledge the assistance of the following colleagues who placed central venous catheters and collected data: Sherif Assaad, Jorg Dziersk, James Helman, Srdjan Jelacic, Stefan Lombaard, Kris Natrajan, Donald Oxorn, Francis Salinas, Lila Sueda, and Peter von Homeyer.

a Before the availability of the Compass device, the traditional method to measure pressure was by use of a standard nonsterile transducer at University of Washington Medical Center, by manometry at Virginia Mason Medical Center, and by manometry or transducing or no measurement at Veterans Affairs Connecticut Medical Center. Traditionally no measurement method was used at Harborview Medical Center. Cited Here...

b Illustrations of the use of the Compass and instructions for use can be found at http://www.miradorbiomedical.com. Cited Here...

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