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