Risk stratification of extravasation during semi-automatic intraosseous device use in a pediatric emergency setting.

BACKGROUND: The semi-automatic intraosseous device (EZ-IO®) is useful for safely securing intraosseous access. There are some complications associated with its use but few studies have examined the risk factors. The present study aimed to investigate the risk factors for extravasation as a complication of EZ-IO use in pediatric patients. METHODS: This study is a secondary analysis of a previous, monocentric, retrospective study conducted in Japan describing the use of EZ-IO in a pediatric emergency department. The patients included in the study were younger than 16 years of age with EZ-IO use at the Tokyo Metropolitan Children's Medical Center between January, 2013 and August, 2018. The factors analyzed included demographic information (sex, age, weight), Glasgow Coma Scale (GCS), diagnosis, bolus infusion, and lidocaine use. The primary endpoint was the odds ratio (OR) and 95% confidence interval (CI) for extravasation incidence. RESULTS: Seventy-two patients were enrolled; 14 of these had extravasation, 39 (54.2%) had a diagnosis of cardiac arrest, and 50 (69.4%) had a GCS score of 8 or less. Statistical analysis demonstrated that the group with a high GCS score was significantly associated with extravasation: GCS (<13) versus GCS (13≦) (OR: 12.25; 95% CI: 2.54-59.15; p < 0.01), GCS (<8) versus GCS (8≦) (OR: 4.78; 95% CI: 1.34-17.01; p = 0.03). CONCLUSIONS: A high GCS score was associated with extravasation in EZ-IO use significantly more often than a low GCS score. No significant difference was found in the other endpoints.

Complete Neurological Recovery After Emergency Burr Hole Placement Utilizing EZ-IO® for Epidural Hematoma.

BACKGROUND: Post-traumatic epidural hematoma (EDH) accounts for 1-3% of pediatric closed head injury admissions. There is a 2.5:1 male predominance. Etiology varies by age; motor vehicle collisions are the primary cause of EDH in adolescents. Post-traumatic EDH accompanies up to 4% of adult head injuries, and is associated with 10% mortality in adults and 5% mortality in children. In North America, standard of care for post-traumatic EDH includes decompressive craniotomy or trepanation via burr hole. Such lifesaving care is typically provided in the operating room by consulting neurosurgery teams or other personnel trained in the use of burr hole equipment. CASE REPORT: The case of a 17-year-old female patient who presented to a community emergency department (ED) after being involved in a motor vehicle collision is discussed. At the scene of the accident, she refused emergency medical services transport and was brought to the ED via private vehicle. She quickly decompensated in the ED and required intubation. Neurosurgical services were not available and transport to the nearest pediatric trauma center was delayed due to weather. Decompression and drainage of her EDH was accomplished with an EZ-IO® driver and intraosseous needle under virtual guidance of a pediatric neurosurgeon until definitive care could be obtained. The patient made a full neurologic recovery. WHY SHOULD AN EMERGENCY PHYSICIAN BE AWARE OF THIS: EDHs have high morbidity and mortality. In settings without access to neurosurgical services, and where ED access to or familiarity with burr hole equipment is limited, the EZ-IO® device may be a temporizing and lifesaving intervention until definitive neurosurgical care can be obtained.

Semi-automatic intraosseous device (EZ-IO) in a paediatric emergency department.

AIM: Intraosseous access is an alternative to conventional intravenous access. A number of studies have demonstrated the utility and safety of EZ-IO, a recently introduced semi-automatic intraosseous device. However, few studies have investigated the use of EZ-IO in the paediatric emergency setting. The aim of this study was to describe the epidemiological characteristics EZ-IO use including complications among paediatric patients in a paediatric emergency department. METHODS: We conducted a retrospective descriptive study enrolling children younger than 16 years who visited our emergency department between January 2013 and August 2018. Data on age, gender, diagnosis, insertion success rate and complications were collected and analysed. RESULTS: Seventy-two patients were enrolled; of these 38 (52.8%) were male. The median age was 9 months (interquartile range: 3-34.5 months). Of the total, 22 (30.6%) received more than one IO insertion. Ninety-seven consecutive IO insertions were identified. The rate of successful insertions was achieved at 92.7% (90 insertions). There were 21 complications (21.6%), including 17 extravasations (17.5%) of fluid and four dermal abrasions (4.1%). We found no cases of complications that may have compromised patient safety. CONCLUSIONS: The success rate of the EZ-IO insertion was high in paediatric patients. However, we found a higher incidence of dermal abrasions, which might be a complication specific to children.

Observational review of paediatric intraosseous needle placement in the paediatric emergency department.

AIM: Intraosseous (IO) access is a life-saving option during resuscitations in the paediatric emergency department (PED). This study aimed to compare success rates and time to placement for Manual IO versus EZ-IO needles in PED patients ≤8 and >8 kg. METHODS: This was a retrospective cross-sectional descriptive study of IO use in a single-centre tertiary PED from 2006 to 2014. Cases were identified through diagnosis codes for IO infusion, cardiopulmonary resuscitation and cardiac arrest and admissions to the intensive care unit. Categorical measures were compared with Z-test for comparison of two proportions and continuous with Student's t-tests. RESULTS: Of 1748 charts screened, 50 had an IO attempted. In patients ≤8 kg, Manual IO had success rate of 55% (17/31) versus 47% (8/17) for EZ-IO (P = 0.61). In patients >8 kg, Manual had success rate of 100% (2/2) versus 93% (14/15) for EZ-IO (P = 0.71). Manual performance was no different for ≤8 kg than >8 kg (P = 0.21), but EZ-IO was less successful for ≤8 kg than >8 kg (P = 0.005). In patients ≤8 kg, Manual IO had a shorter time to placement at 4.5 min versus 12.8 for EZ-IO (P = 0.02). CONCLUSION: We observed no difference in performance between Manual and EZ-IO devices in children ≤8 kg, but the Manual IO were placed more quickly. We observed lower success rates with EZ-IO devices in children ≤8 kg compared to >8 kg. Future investigations should focus specifically on training for IO placement in children ≤8 kg.

Comparison of Two Intraosseous Devices: The NIO Versus the EZ-IO by Novice Users-A Randomized Cross Over Trial.

BACKGROUND: During resuscitation in the field, intraosseous (IO) access may be achieved using a variety of available devices, often attempted by inexperienced users. AIM: We sought to examine the success rate and ease-of-use ratings of an IO device, the NIO® (New Intraosseous Persys Medical, Houston, TX, USA) in comparison to the Arrow® EZ-IO® (Teleflex Medical Research Triangle Park, NC, USA) by novice users. METHODS: We performed a randomized crossover trial. The study model was a porcine hind leg which was cut distally in order to expose the marrow. The Study population was composed of pre-graduate medical students without prior experience in IO use, all designated future field physicians. The students underwent instruction and practiced the use of both devices. After practice completion, each student attempted a single IO insertion with both devices sequentially in randomized fashion. Success was defined as a flow of fluid through the bone marrow after a single IO attempt. Investigators which determined the success rate were blinded to the used device. RESULTS: 50 users (33 males, 17 females) participated in the trial, mean age of 21.7 years (±1). NIO users were successful in 92% (46/50) attempts while EZ-IO user success rate was 88% (44/50). NIO success rates were comparable to those of EZ-IO (p = NS). Results were similar when examining only the initial device used. Median score of ease of use was 4 (5 point Likert scale) in both devices (p = NS). 54% (27/50) of the participants preferred using the EZ-IO over the NIO (p = NS). CONCLUSION: Novice users were equally successful in establishing IO access with the NIO® in comparison to the EZ-IO® in a porcine model.

Comparison of tranexamic acid plasma concentrations when administered via intraosseous and intravenous routes.

INTRODUCTION: There is a lack of information regarding intraosseous (IO) administration of tranexamic acid (TXA). Our hypothesis was that a single bolus IO injection of TXA will have a similar pharmacokinetic profile to TXA administered at the same dose IV. METHODS: Sixteen male Landrace cross swine (mean body weight 27.6±2.6kg) were divided into an IV group (n=8) and an IO group (n=8). Each animal received 30mg/kg TXA via an IV or IO catheter, respectively. Jugular blood samples were collected for pharmacokinetic analysis over a 3h period. The maximum TXA plasma concentration (Cmax) and corresponding time as well as distribution half-life, elimination half-life, area under the curve, plasma clearance and volume of distribution were calculated. One- and two-way analysis of variance for repeated measures (time, group) with Tukey's and Bonferonni post hoc tests were used to compare TXA plasma concentrations within and between groups, respectively. RESULTS: Plasma concentrations of TXA were significantly higher (p<0.0001) in the IV group during the TXA infusion. Cmax occurred at 4min after initiation of the bolus in the IV group (9.36±3.20ng/µl) and at 5min after initiation of the bolus in the IO group (4.46±0.49ng/µl). Plasma concentrations were very similar from the completion of injection onwards. There were no significant differences between the two administration routes for any other pharmacokinetic variables measured. CONCLUSION: The results of this study support pharmacokinetic bioequivalence of IO and IV administration of TXA.

Intraosseous access EZ-IO in a prehospital emergency service.

BACKGROUND: Several scientific and professional associations have made reports and recommendations to regulate the use of intraosseous (IO) access as an alternative to conventional intravenous access (IA) in emergency situations when IA cannot be obtained. It has been well documented that IO access is safe and effective for fluid resuscitation, drug delivery, and blood collection. IO access is attainable in all age groups. OBJECTIVE: The objective of this prospective study was to test the use of a semi-automatic IO infusion system (EZ-IO) as an alternative to vascular access in critical patients treated in a prehospital emergency setting. METHOD: This prospective, cross-sectional study included patients who required immediate peripheral vascular access. This study was performed by reviewing clinical records and through a questionnaire (created by and for nurses who perform the insertion with the EZ-IO). RESULTS: During the study period we identified 107 patients who underwent EZ-IO insertion (114 insertions were performed). Patients were predominantly male (66%) and middle aged (mean age 56 years; range 3-94). Overall, insertion was performed via the proximal tibia (49.4%) distal tibia (25.2%), radius (14.9%), and humerus (10.5%). During the study period, 14 insertions were performed in 2007, 44 in 2008, and 56 in 2009. A majority of patients (50.9%) had medical cardiac arrest, (25.4%) were injured trauma patients, and 12.3% had traumatic cardiac arrest. All patients were transported to a hospital with 2 sites of peripheral vascular access. The first site of access in these patients was IO (100% of cases) and the second site (in 79% of cases) was peripheral intravenous access. All EZ-IO insertions were achieved within 30 seconds and were successful upon the first attempt. CONCLUSION: The use of the EZ-IO provides a quick (100% performed within 30 seconds), easy, and reliable alternative to conventional venous access in critically ill patients. Traditional peripheral venous access requires a minimal preparation that can delay initial treatment in critically ill patients and cause possible interference with resuscitation. The main advantage of using EZ-IO is to obtain secure, immediate, noncollapsible peripheral venous access in critically ill patients. It is possible to obtain a second site of access such as peripheral venous access to administer fluids and drugs, which can improve survival rates.

Intraosseous vascular access using the EZ-IO can be safely maintained in the adult proximal humerus and proximal tibia for up to 48 h: Report of a clinical study.

BACKGROUND: Historically, intraosseous (IO) vascular access devices cleared to market by the US FDA have been restricted to 24-h use. An observational study was conducted to determine the safety of IO access for a period up to 48 h in adult volunteers. METHODS: A 2-arm randomized, stratified, parallel assignment, prospective interventional study was conducted at ICON Early Phase Services in San Antonio, Texas, United States. Study subjects were adult volunteers who were healthy or with a history of mild to moderate renal disease and/or controlled diabetes. Subjects were randomized to receive IO access (Arrow EZ-IO Vascular Access System, Teleflex Medical Incorporated, Morrisville, NC, USA) in the proximal humerus or the proximal tibia and maintain the indwelling catheter for 48 h. Subjects were monitored for the entire dwell time. A culture specimen was drawn from the indwelling catheter tip before removal and insertion site x-rays were taken. RESULTS: 121 subjects were randomized: 79 healthy, 39 with diabetes, and three with diabetes and renal insufficiency. The mean catheter dwell time was 48.0 ± 0.2 h. Overall first attempt success rate was 98.4%. Infusion pain was the most commonly reported adverse event. There were no serious complications or unanticipated adverse events. CONCLUSIONS: This is the first known study examining the safety of IO access over a 48-h dwell time. The study corroborates the literature findings, demonstrates device safety, and provides evidence supporting the extended indication for a dwell time to 48 h in adult patients. IO placement and infusion best practices/guidelines were confirmed or established.

A pilot study comparing bone marrow aspirates and venous blood for emergency point-of-care blood parameters in healthy dogs.

OBJECTIVE: To compare intravenous and intraosseous blood aspirates using point-of-care diagnostic equipment available in veterinary hospitals. DESIGN: Prospective study. SETTING: Private referral hospital. ANIMALS: Dogs undergoing a tibial plateau leveling osteotomy or extracapsular anterior cruciate ligament stabilization procedure were enrolled. METHODS: Under general anesthesia, simultaneous 0.5 mL intravenous and intraosseous blood samples were collected from the jugular vein and proximal tibia, respectively. Samples were evaluated in duplicate within 10 minutes of collection and averaged for each of the following parameters: blood urea nitrogen (BUN), glucose, packed cell volume, total plasma protein (TPP), plasma lactate, sodium, potassium, chloride, urea, glucose, pH, anion gap, pO2, and pCO2 . Normalcy was tested with Kolmogorov-Smirnov test. A Student's t-test and Bland-Altman plot were used to compare intravenous and intraosseous samples. RESULTS: Twelve dogs were recruited into the study. There were statistically significant differences between intravenous and intraosseous samples for sodium (P = 0.0216), chloride (P = 0.0225), BUN (P = 0.014), and potassium (P < 0.0001), respectively. No significant differences were detected for the other parameters evaluated. DISCUSSION: The intraosseous space provides an easily accessible, noncollapsible alternative for assessing blood parameters. Omitting potassium, the statistically significant differences noted between sites was not felt to be clinically significant. Although statistically insignificant, the large difference in hematocrit values indicates that the samples should not be used interchangeably. CONCLUSION: Intraosseous aspirates, excluding potassium and hematocrit, appear to be a reliable alternative for assessing most point-of-care analytes in healthy dogs, although a larger sample size should be investigated. The application of these data in shock patients is unknown.

Comparison of two different intraosseous access methods in a physician-staffed helicopter emergency medical service - a quality assurance study.

BACKGROUND: Intravenous access in critically ill and injured patients can be difficult or impossible in the field. Intraosseous access is a well-established alternative to achieve access to a noncollapsible vascular network. We wanted to compare the use of a sternal and tibial/humeral intraosseous device in a physician-staffed helicopter emergency medical service. METHODS: The helicopter emergency medical service in Bergen, Norway, is equipped with two different intraosseous devices, the EZ-IO and FAST-Responder. We compared insertion time, insertion sites, flow, indication for intraosseous access, and complications between the tibial/humeral and sternal techniques. RESULTS: In 49 patients, 53 intraosseous insertions were made. The overall intraosseous rate was 1.5% (53 insertions in 3600 patients treated). The main patient categories were cardiac arrest and trauma. Overall, 93.9% of the insertions were successful on the first attempt. The median insertion time using EZ-IO was 15 s compared to 20 s using FAST-Responder. Insertion complications registered using the EZ-IO included extravasation, aspiration failure and insertion time > 30 s. Using FAST-Responder, there were reported complications such as user failure (12.5%) and insertion time > 30 s (12.5%). Regarding the flow, we found that 35.1% of the EZ-IO insertions experienced poor flow and needed a pressure bag. With FAST-Responder, the flow was reported as very good or good in 85.7%, and no insertions had poor flow. CONCLUSION: Intraosseous access seems to be a reliable rescue technique in our helicopter emergency medical service, with high insertion success rates. EZ-IO was a more rapid method in gaining vascular access compared to FAST-Responder. However, FAST-Responder may be a better method when high-flow infusion is needed. Few complications were registered with both techniques in our service.

EZ-IO(®) intraosseous device implementation in German Helicopter Emergency Medical Service.

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.