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.

Powered bone marrow biopsy procedures produce larger core specimens, with less pain, in less time than with standard manual devices.

Bone marrow sampling remains essential in the evaluation of hematopoietic and many non-hematopoietic disorders. One common limitation to these procedures is the discomfort experienced by patients. To address whether a Powered biopsy system could reduce discomfort while providing equivalent or better results, we performed a randomized trial in adult volunteers. Twenty-six subjects underwent bilateral biopsies with each device. Core samples were obtained in 66.7% of Manual insertions; 100% of Powered insertions (P=0.002). Initial mean biopsy core lengths were 11.1±4.5 mm for the Manual device; 17.0±6.8 mm for the Powered device (P<0.005). Pathology assessment for the Manual device showed a mean length of 6.1±5.6 mm, width of 1.0±0.7 mm, and volume of 11.0±10.8 mm(3). Powered device measurements were mean length of 15.3±6.1 mm, width of 2.0±0.3 mm, and volume of 49.1±21.5 mm(3) (P<0.001). The mean time to core ejection was 86 seconds for Manual device; 47 seconds for the Powered device (P<0.001). The mean second look overall pain score was 33.3 for the Manual device; 20.9 for the Powered (P=0.039). We conclude that the Powered biopsy device produces superior sized specimens, with less overall pain, in less time.

A new study of intraosseous blood for laboratory analysis.

CONTEXT: Intraosseous (IO) blood is frequently used to establish a blood chemistry profile in critically ill patients. Questions remain regarding the reliability of IO blood for laboratory analysis and established criteria regarding the amount of marrow/blood to waste before taking an IO sample are not available. OBJECTIVES: To evaluate IO-derived blood for routine laboratory blood tests needed in the care of critically ill patients and to determine the amount of marrow/blood to waste before drawing blood from the IO space for laboratory analysis. DESIGN: Blood samples were drawn from peripheral veins of 10 volunteers. Within 5 minutes, 2 IO blood samples were obtained; one following 2 mL of waste and another following 6 mL of waste. Samples were analyzed for complete blood count and chemistry profile. Values were analyzed using Pearson correlation coefficients. Levels of significance were determined using the t distribution. Mean values for the draws were calculated and compared, with the intravenous blood sample serving as a control for the IO samples. RESULTS: There was a significant correlation between intravenous and IO samples for red blood cell counts and hemoglobin and hematocrit levels but not for white blood cell counts and platelet counts. There was a significant correlation between intravenous and IO samples for glucose, blood urea nitrogen, creatinine, chloride, total protein, and albumin concentrations but not for sodium, potassium, CO(2), and calcium levels. CONCLUSIONS: When venous blood cannot be accessed, IO blood aspirate may serve as a reliable alternate, especially for hemoglobin and hematocrit levels and most analytes in a basic blood chemistry profile. Exceptions are CO(2) levels and platelet counts, which may be lower, and white blood cell counts, which may appear elevated.

Rotary powered device for bone marrow aspiration and biopsy yields excellent specimens quickly and efficiently.

Recently, a new FDA-cleared battery powered bone marrow biopsy system was developed to allow operators access to the bone marrow space quickly and efficiently. A pre-clinical evaluation of the device (OnControl, Vidacare Corporation, San Antonio, TX, USA) on anesthetized pigs was conducted, in addition to a clinical evaluation in hematology clinic patients requiring a bone marrow biopsy. Twenty-six samples were collected from the swine model. No cellular artifact or thermal damage was reported in any of the samples obtained. For the clinical evaluation of the device, 16 patients were recruited. Mean time from needle contact with skin to needle removal was 38.5 +/- 13.94 seconds. No complications were reported. In this study, the manual and powered samples were equivalent in specimen quality. In the patients evaluated, the device was safe, easy to use and the mean procedural time was significantly faster than previously reported with a manual technique.

Does intraosseous equal intravenous? A pharmacokinetic study.

STUDY OBJECTIVE: Despite the growing popularity of intraosseous infusion for adults in emergency medicine, to date there has been little research on the pharmacokinetics of intraosseously administered medications in humans. The objective of the study was to compare the pharmacokinetics of intraosseous vs intravenous administration of morphine sulfate in adults. METHODS: The study followed a prospective, randomized, crossover design. Each subject was equipped with an indwelling intraosseous access device and an intravenous line. Subjects were randomized to receive a 5-mg bolus of morphine sulfate infused intraosseously or intravenously, followed by the alternate administration route 24 hours later. Serial venous blood samples (5 mL) were taken at baseline and at 13 time points over 8 hours postinfusion. Blood samples were analyzed for morphine concentration by radioimmunoassay. Pharmacokinetic parameters were calculated from the data, including maximum plasma concentration (Cmax), time to maximum concentration (Tmax), and area under plasma concentration-time curve (AUC), among others. Data were analyzed by analysis of variance. RESULTS: No statistically significant differences were observed between intraosseous and intravenous administration of morphine sulfate for nearly all of the pharmacokinetic parameters including Cmax (235 +/- 107 vs 289 +/- 197 ng/mL, mean +/- SD, i.o. vs i.v., respectively), Tmax (1.3 +/- 0.5 vs 1.4 +/- 0.5 minutes), and AUC(0-infinity) (4372 +/- 1785 vs 4410 +/- 1930 ng min(-1) mL(-1)). There was, however, a statistically significant difference in the volume of distribution in the central compartment, V(d) (P = .0247), which in the opinion of the investigators was thought to be due to a minor deposition effect near the intraosseous port or in the bone marrow. CONCLUSION: The results support the bioequivalence of intraosseous and intravenous administration of morphine sulfate in adults.