Comparison Between a Color-only Method and a Food and Drug Administration-approved Validation Method for a Pediatric Color-coded Syringe Using Midazolam: A Randomized Crossover Trial.

OBJECTIVE: The objective of this study was to assess the use of a color-only method syringe for accuracy and timeliness when administrating midazolam. This method was compared with a U.S. Food and Drug Administration (FDA)-approved validation method. METHODS: A prospective, randomized, crossover trial was conducted to compare the dosing accuracy and timeliness of the color-only syringe method versus the validation method. Twenty-five participants prepared pediatric midazolam doses according to their preferred method, a FDA-approved validation method, and a color-only method. Primary endpoints included dosing accuracy and time to medication administration. RESULTS: The preferred 3-kg calculations had a median margin of error of 5.6% and a median time to completion of 55.6 seconds. The color-only method took less time to complete than the validation method (median time: 29.5 seconds vs 58.2 seconds). There was no statistically significant difference in errors between the color-only method and the validation method. None of the participants reported a mistake using the color-only method, whereas 25% (5/20) reported a mistake using the validation method. Only 20% (4/20) of participants believed that the validation method found or eliminated any mistakes. There were 8 medication errors identified when participants used the method of choice, 4 with the validation method, and 1 with the color-only method. CONCLUSIONS: There was no significant difference in dosing errors between the FDA-approved validation method and the color-only method. Use of a color-only method did reduced time to medication administration when compared with a preferred method and an FDA-approved validation method.

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.

Intraosseous line placement for antidote injection by first responders and receivers wearing personal protective equipment.

STUDY OBJECTIVE: Early antidotal therapy may be lifesaving in hazardous materials victims. Intravenous line placement is difficult while wearing personal protective equipment (PPE). We assessed the ability of protected, experienced first responders and limited-experience first receivers to place intraosseous (IO) lines for antidote administration. METHODS: Six first responders donned 4 (A, B, C, and D) and 12 first receivers donned 2 (C and D) United States Environmental Protection Agency PPE levels in random order and then placed IO lines in 1 of 4 anatomical sites in 12 anesthetized Spanish goats. Observers timed interventions until bolus injection of isotonic sodium chloride solution. RESULTS: First responders placed IO lines successfully in 100% of cases. The median (interquartile range) times to completion (in seconds) were as follows: level A, 43.5 (23.0); B, 45.0 (29.0); C, 40.0 (15.0); D, 30.0 (17.0). First receivers placed IO lines successfully in 91% of cases. The median (interquartile range) times to completion (in seconds) were as follows: level C, 42.0 (19.5); D, 37.0 (11.0). There were no significant differences in time to completion among PPE levels (overall or pairwise) or between operator groups. Two (4%) of 48 line placements resulted in recognized extravasation due to penetration of the opposite cortex. Infusions were completed successfully. CONCLUSION: Hazardous materials first responders and receivers can effectively place IO lines in a goat while wearing PPE. Intraosseous lines may facilitate earlier administration of antidotes in hazardous materials victims.

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.