Page 84 - JSOM Winter 2023

rate of the sternal-IO access in patients at risk for circulatory FIGURE 1 Images of TALON IO and FAST1 IO devices.
collapse, as prior work has focused on a more stable patient
population. Further, we conducted a pilot clinical study to test
our hypothesis that placement of a sternal-IO device represents
a viable option for early vascular access and resuscitation of
critically injured civilian trauma patients.

Methods

This study was approved by the University of Pennsylvania
Institutional Review Board and informed consent was waived.
The investigators adhered to policies regarding the protection
of human subjects as prescribed by the Code of Federal Reg-
ulations Title 45, Volume 1, Part 46; Title 32, Chapter 1, Part
219; and Title 21, Chapter 1, Part 50 (Protection of Human thoracotomy (EDT) or autopsy, was considered as failure.
Subjects). 12,13 Considering that our institution was trialing a limited number
of devices, this outcome was immediately discussed with the
Patients and Data Collection faculty member for performance improvement. Prior to using
We conducted a retrospective observational study of patients these devices, physicians attended a virtual training session or-
presenting to our large, urban, academic, civilian medical cen- ganized by the vendor and/or a personal in-service demonstra-
ter from 1 October 2020 to 30 June 2021. Data were curated tion by the trauma program manager.
from our institutional trauma registry and electronic medical
records (EMR). As the sternal-IO device was novel to our di- Secondary outcomes included the type and location of vascular
vision, clinicians understood that the insertion attempts would access in relation to the patient’s underlying injury mechanism
be scrutinized during the performance improvement process, (potentially impeded IO placement), return of spontaneous
which would later supplement the retrospective EMR review. circulation (ROSC), operating room interventions, 6-hour
We included all patients who received a sternal-IO device in survival, and discharge survival. As these devices were being
our trauma resuscitation bay. Patients were excluded from the deployed during periods of shock, such that, the clinician
analysis if they were pregnant, incarcerated, or younger than would not know if a true underline injury existed, potentially
18 years of age. impeded IOs were defined as IOs placed with a possible injury,
including potential fractures, proximal to the IO placement.
Exposures For example, if a patient had a right tibial-IO placement and
In this pilot study, we evaluated two different sternal-IO de- an abdominal gunshot wound, this was classified as a poten-
™
vices: TALON (Tactically Advanced Lifesaving IO Needle, tially impeded IO placement. Patients were classified as dead
™
Teleflex, https://myteleflex.com) and FAST1 (First Access for on arrival if no signs of life were detected on presentation
Shock and Trauma, Teleflex, https://www.teleflex.com). The to the trauma bay. Finally, the patient demographics, injury
TALON IO device was deployed over a 3-month period from mechanism, and details of resuscitation, including the infused
Fall 2020 to the beginning of 2021, until our institution used blood products and medications, were analyzed.
the supplied devices. The TALON IO utilizes a baseplate with
anchoring needles that inserts into the manubrium, which al- Statistical Analysis
lows safe placement of the 15-gauge infusion needle with man- Medians and interquartile ranges (IQR) were determined. The
ual pressure (Figure 1). The FAST1 IO device utilizes a ring of analysis was performed using STATA version 16.0 (StataCorp,
stabilization needles (which are removed during the insertion) https://www.stata.com/). The manuscript was prepared in ac-
around a central infusion needle (Figure 1). A spring-loaded cordance with the STROBE (Strengthening the Reporting of
deployment mechanism is activated when adequate down- Observational Studies in Epidemiology) guidelines (Supple-
ward axial pressure is applied to the FAST1 handle. The device mental Digital Content). 14
was on backorder and therefore deployed in late Spring 2021
over a 1-week timeframe.
Results
As a pilot study, our institution allowed limited access to the The analysis included nine patients who received the ster-
device. Accordingly, our division limited the deployment of the nal-IO device in the pilot study. All patients were male with a
sternal-IO device at the user’s discretion to a cohort of patients median age of 26 years (IQR 24–31 y) (Table 1). In addition,
not expected to survive. This allowed for extensive review of all nine were victims of gunshot wounds and brought to our
the device in our performance improvement program before it trauma bay by police transport as part of a Philadelphia Po-
was considered for patients who were more likely to survive. lice Department initiative that allows police officers to trans-
Additionally, the treating physician had the final authority to port trauma victims directly from the scene of injury (Table
decide whether or not to deploy the device. 1). Eight patients arrived after short transport times with no
signs of life, and the ninth patient presented in extremis with
Outcomes a witnessed arrest shortly thereafter. All nine underwent EDT,
The primary outcome was the ability to successfully implant including six clamshell thoracotomies. In addition, all patients
a sternal-IO device. A successfully implanted sternal-IO device required ED intubation and vigilant monitoring of resuscita-
was judged by its ability to facilitate infusion of blood prod- tion with adjunctive medications and procedures, such as ar-
ucts or medications. Additionally, visualization of malposi- terial lines, venous access other than sternal IO, thoracostomy
tion, including visualization during an emergency department tubes, and tourniquets.

82 | JSOM Volume 23, Edition 4 / Winter 2023