“The Esophageal Cooling Device”: A New Way to Achieve Targeted Temperature Management-Juniper Publishers
JUNIPER PUBLISHERS-OPEN ACCESS JOURNAL OF CARDIOLOGY & CARDIOVASCULAR THERAPY
Abstract
Targeted temperature management (TTM) is a standard
of care following cardiac arrest, but the therapy is often
underutilized. Workflow interruptions and adverse events associated with
existing TTM devices contribute to under utilization, which has prompted
the development of new technologies. The purpose of this article is to
summarize the rationale behind evaluating a new TTM device, the
Esophageal Cooling Device (ECD).
Introduction
Targeted temperature management (TTM) has become a
standard of care following cardiac arrest [1,2] and the benefits of this
therapy are well established [3,4]. However, not all patients who
should receive this therapy do. Studies have documented TTM under
utilization at the hospital level [5,6] but have not extensively
documented why some facilities fail to initiate TTM for some patients or
never fully implement a TTM protocol at all. Given that TTM was first
included in the American Heart Association Guidelines in 2005, ignorance
of the practice is an unlikely explanation. Closer examination of the
current technologies used to deliver TTM provides an alternative reason
for under utilization.
Over the last decade, advanced TTM systems (i.e.,
those that incorporate servo-controlled temperature monitoring to
automatically adjust therapy to patient needs) used one of two methods
to affect heat transfer for cooling: intravascular convection and
surface conduction. Intravascular methods use specially designed
catheters that are inserted into the central venous system. This method
promotes efficient heat transfer but patients are at risk of developing
blood stream infections and blood clots [7,8] and TTM initiation can be
significantly delayed, sometimes for hours, when a physician is not
available to place the line. Surface devices use pads or blankets to
cover the patient and transfer heat through the skin. This configuration
is non-invasive, but it is also less efficient. Surface cooling is
associated with skin damage [9,10] and patient access is obscured. To
place most surface devices, 2-3 nurses must work together to manipulate
the patient and then must ensure that the device remains clean
throughout the course of treatment. Thus, while there are several
devices available to clinicians to effectively perform TTM, there is
also an opportunity for improvement. This in turn has inspired the
development of new technologies that are now available for
implementation, either in conjunction with, or as a replacement for,
existing TTM methods.
One such technology, the Esophageal Cooling Device
(ECD; Advanced Cooling Therapy, Inc., Chicago, IL) was approved for
marketing by the FDA in 2015. At that time, Peace Health St. Joseph
Medical Center in Bellingham, WA, had successfully cooled over 700 PCA
patients using a surface method. Patient outcomes were consistent with
the literature; approximately 51% of patients were discharged from the
ICU with good neurological outcomes, as measured by the modified Rankin
Scale (mRS). However, the blanket-style system obscured patient access
and sometimes interfered with nursing care.
The Department of Emergency Medicine evaluated the
ECD on two key criteria: 1) that the clinical performance of
the ECD was equivalent to the surface system in use, and 2)
that staff members experienced less interference with clinical
tasks. Results from published pre-clinical data [11-14], case
studies [15-18], and prospective clinical evaluations [19]
suggested that equivalent performance was attainable. The
internal placement of the device, which replaces a standard OG
tube (Figure 1), also suggested that reduced interference with
clinical tasks was likely.
At the time of this writing, the Emergency Department
Cardiac Cath Lab, and ICU have used the ECD to deliver TTM
to 30 consecutive patients. The ECDs were placed by ER, ICU,
and STAT nurses, who expressed satisfaction with the training
burden required to demonstrate competence for correct
insertion and use. The ECD connects to the same heat exchange
unit that was already in use in the department (Blanketrol III,
Cincinnati Sub-Zero, Cincinnati, OH), which helped accelerate
the learning curve. In some instances, simple modifications
were employed, such as restricting water outflow to make
the device more rigid during placement or briefly deflating
the ET tube balloon, for challenging insertions. Clinical staff
members observed a rapid start to cooling (typically slightly
over 1°C/hr) and stable maintenance temperatures (±1°C from
target) throughout treatment, consistent with other clinical
performance evaluations [20]. Nurses were also pleased with
the flexibility the ECD offered, as cooling blankets could be
added or removed as needed to best meet evolving patient
needs during TTM. In addition, cardiologists responded
favorably to the ECD because it caused almost no distortion in
the catheterization laboratory. One shortcoming of the ECD is
that it does not currently support feeding through the central
lumen, though this feature will be included in future iterations
[21].
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