Resuscitation 88 (2015) 43–47

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Clinical Paper

EZ-IO® intraosseous device implementation in German Helicopter Emergency Medical Service夽 Matthias Helm a,∗,1 , Benedikt Haunstein a,1 , Thomas Schlechtriemen c , Matthias Ruppert b , Lorenz Lampl a , Michael Gäßler b a Department of Anaesthesiology & Intensive Care Medicine – Section Emergency Medicine/HEMS “Christoph 22”, Armed Forces Medical Centre Ulm, Germany b Department of Medicine – ADAC Luftrettung (Subsidiary of the German Automobile Association), Munich, Germany c Medical Quality Management – ADAC Luftrettung (Subsidiary of the German Automobile Association), Munich, Germany

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Article history: Received 17 October 2013 Received in revised form 10 December 2014 Accepted 20 December 2014 Keywords: Emergency medicine EZ-IO® Helicopter Emergency Medical Service Intraosseous vascular access Vascular access

a b s t r a c t Background: Intraosseous access (IO) is a rapid and safe alternative when peripheral venous access is difficult. Our aim was to summarize the first three years experience with the use of a semi-automatic IO device (EZ-IO® ) in German Helicopter Emergency Medical Service (HEMS). Methods: Included were all patients during study period (January 2009–December 2011) requiring an IO access performed by HEMS team. Outcome variables were IO rate, IO insertion success rates, site of IO access, type of EZ-IO® needle set used, strategy of vascular access, procedure related problems and operator’s satisfaction. Results: IO rate was 0.3% (348/120.923). Overall success rate was 99.6% with a first attempt success rate of 85.9%; there was only one failure (0.4%). There were three insertion sites: proximal tibia (87.2%), distal tibia (7.5%) and proximal humerus (5.3%). Within total study group IO was predominantly the second-line strategy (39% vs. 61%, p < 0.001), but in children < 7 years, in trauma cases and in cardiac arrest IO was more often first-line strategy (64% vs. 28%, p < 0.001; 48% vs. 34%, p < 0.032; 50% vs. 29%, p < 0.002 respectively). Patients with IO access were significantly younger (41.7 ± 28.7 vs. 56.5 ± 24.4 years; p < 0.001), more often male (63.2% vs. 57.7%; p = 0.037), included more trauma cases (37.3% vs. 30.0%; p = 0.003) and more often patients with a NACA-Score ≥ 5 rating (77.0% vs. 18.6%; p < 0.001). Patients who required IO access generally presented with more severely compromised vital signs associated with the need for more invasive resuscitation actions such as intubation, chest drains, CPR and defibrillation. In 93% EZ-IO® needle set handling was rated “good”. Problems were reported in 1.6% (needle dislocation 0.8%, needle bending 0.4% and parafusion 0.4%). Conclusions: The IO route was generally used in the most critically ill of patients. Our relatively low rate of usage would indicate that this would be compatible with the recommendations of established guidelines. The EZ-IO® intraosseous device proved feasible with a high success rate in adult and pediatric emergency patients in HEMS. © 2014 Elsevier Ireland Ltd. All rights reserved.

1. Introduction In the out-of-hospital emergency setting, rapid vascular access is often required in order to administer drugs and/or fluids

夽 A Spanish translated version of the abstract of this article appears as Appendix in the final online version at http://dx.doi.org/10.1016/j.resuscitation.2014.12.015. ∗ Corresponding author at: Armed Forces Medical Centre Ulm, Department of Anaesthesiology & Intensive Care Medicine, Section Emergency Medicine – HEMS “Christoph 22”, Oberer Eselsberg 40, 8970 Ulm, Germany. E-mail address: [email protected] (M. Helm). 1 These authors contributed equally to this manuscript. http://dx.doi.org/10.1016/j.resuscitation.2014.12.015 0300-9572/© 2014 Elsevier Ireland Ltd. All rights reserved.

in critical patients.1,2 Peripheral venous cannulation remains the standard of care, but may altogether difficult to achieve and time-consuming in life-threatening situations.3 As an effective alternative to peripheral venous cannulation, intraosseous (IO) access is increasingly recognized. Various organizations recommend IO access as the immediate alternative route if intravenous access cannot be rapidly obtained in pediatric and adult patients.4–10 The IO access is a rapid, simple and safe procedure with an effectiveness equivalent to peripheral venous cannulation in terms of pharmacokinetic and clinical efficacy.11–13 Furthermore, the IO access is characterized by a rapid learning curve.3

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M. Helm et al. / Resuscitation 88 (2015) 43–47

The recent development of mechanical IO infusion devices has increased the options available for IO access. Within this context, the EZ-IO® a semi-automatic IO device with a battery powered needle driver has been introduced over the last ten years.3,14 This IO device can be used not only in children and adults but at three different insertion sites (proximal and distal tibia as well as proximal humerus).3 In 2009 the ADAC (German Automobile Club) Air Rescue Service, which operates 35 HEMS bases throughout Germany, standardized the equipment for IO access and introduced the EZIO® device to all HEMS bases, replacing previously used varying IO systems. In this observational study we summarize the first three years experience with this IO device. 2. Methods 2.1. Study design We conducted a retrospective analysis of IO needle insertions performed in context with all HEMS missions during the first three years (January 2009–December 2011) after introduction of the EZ-IO® system (Vidacare, San Antonio, TX, USA). The study was approved by the Ulm University, School of Medicine institutional ethics committee (Reference no. 272/12). Analysis included retrospective chart review of prehospital mission records in terms of patients characteristics, vital parameters upon arrival at scene and of invasive procedures performed during prehospital treatment (endotracheal intubation, chest tubing, defibrillation and chest compressions). Furthermore, the analysis included retrospective chart review of the systemwide uniform EZ-IO® feedback forms in terms of overall and annually IO rate, IO canula type used, IO strategy, IO insertion site, IO success rate as well as IO needle set handling and procedural complications. Only complete datasets were included in analysis. 2.2. EZ-IO® intraosseous infusion system EZ-IO®

The system is a battery powered driver and specially designed cutting 15 gauge stainless steel IO needles of 3 different lengths: A 15 mm needle set, designed for patients with 3–39 kg body weight (BW), and for patients with minimal tissue over the insertion site as well as a 25 mm needle set for patients with >39 kg BW, or for patients who have too much tissue over the insertion site for the 15 mm needle set to be used. The 45 mm needle set is designed for patients with >39 kg BW who have excessive tissue over the targeted insertion site (e.g. edema, large musculature, obesity). The 45 mm needle set is ideal for the humerus site in patients over 39 kg. The EZ-IO® insertion procedure itself was performed according to the recommendations of the manufacturer (Vidacare, San Antonio, TX, USA; see also: www.arrowezio.com). 2.3. Outcome measures The primary outcome variables were IO insertion success rates (overall success rate, 1st.–3rd. IO attempt success, failed IO attempt). Secondary outcome variables comprised the site of IO access (proximal or distal tibia, proximal humerus), type of EZ-IO® needle set used (15 mm, 25 mm, 45 mm), strategy of vascular access (IO as first-line or second-line vascular access strategy), immediate procedure related problems, and operator’s subjective satisfaction with the device (rated as: good, difficult, failed). There are reports of an excessive increase in IO access attempts and unexpected high overall IO rates after introduction of the EZ-IO® system in regional EMS systems in Germany.14 This might be an indicator for an extremely generous indication for IO access, probably not in line with generally

accepted recommendations/guidelines.4–10 Therefore, tertiary outcome variables comprised overall IO rate and annually IO rates; furthermore, we tried to analyze, whether the indication for IO access attempt was more or less in line with generally accepted recommendations/guidelines. In view of the retrospective character of this analysis, we had to look at “indirect” parameters to answer this question, such as the degree of illness/injury severity (NACAScore), state of vital parameters upon arrival at scene (GCS, blood pressure, oxygen saturation etc.) as well as the need for invasive procedures (endotracheal intubation, chest tubing, external chest compression, defibrillation). A high degree of injury severity, seriously compromised vital parameters upon arrival at scene and the need for invasive procedures during prehospital management are expected more often in patients in whom an IO access attempt is necessary (IO-group) than in patients without (non-IO-group). The current published German recommendations for the use of IO vascular access in emergency medicine recommend the intraosseous route when vascular access is absolutely necessary but intravenous access fails or a delay in establishing a vascular access will compromise the timely treatment of the patient.10 Therefore, two strategies based on experienced “clinical judgement” exist: (1) IO as first-line vascular access strategy is used when there is an assumed delay in achieving vascular access by intravenous attempts and thus IO is chosen as first approach to the vascular system. (2) IO as second-line vascular access strategy describes IO usage after failed intravenous attempts. There are reports of a significantly more frequently first-line strategy in children < 7 years and in patients with cardiac arrest.16 Therefore, further outcome variables comprised first-line and second-line IO vascular access strategy rate within total study group as well as various subgroups (children < 7 years vs. children ≥ 7 years/adults; trauma vs. nontrauma; cardiac arrest vs. spontan. circulation). 2.4. Statistics Study data were collected in a separate research database (Microsoft® Excel 2010, Microsoft Corporation Redmond, USA) and evaluated using SPSS software (Version 19.0, SPSS Inc., Chicago, USA). Categorical data was summarized by means of relative and absolute frequencies. Quantitative data was summarized using mean and standard deviation (SD). Due to non-normally distributed data, non-parametric methods for evaluation were used (Chisquare test and unpaired t-test). A p-value