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.

Longitudinal dialysis adequacy and clinical performance of the VectorFlow hemodialysis catheter: a prospective study.

PURPOSE: To report clinical performance and longitudinal assessment of hemodialysis adequacy with the Arrow-Clark VectorFlow catheter, a symmetrical-tip device with a distal lumen configuration designed to reduce platelet shear stress and catheter thrombosis. METHODS AND MATERIALS: We prospectively enrolled patients who required de novo placement of a chronic tunneled catheter for hemodialysis or exchange of a dysfunctional catheter as part of an Institutional Review Board (IRB)-approved protocol. Catheter patency, Kt/V, mean blood-flow (Qb), and pump pressures were obtained at baseline and at monthly intervals to 90 days. RESULTS: Forty-six subjects were enrolled into the study. During the 90-day observation period, maximum blood-flow rate averaged 355-398 mL/minute; mean Qb averaged 333-392 mL/minute. Mean Kt/V values were consistently ≥1.5. Dwell-time was 15-114 days, for a total of 2997 catheter days (mean 71.4 days). Excluding patients who died during the study and those receiving surgical access, overall intervention-free catheter patency rate was 94.9%, 92.2% and 88.8% at days 30, 60, 90, respectively. There were no acute complications. During the follow-up period, three patients developed complications (6.5%). Two catheter infections occurred (0.7/1000 catheter days) and one catheter malfunctioned; a rate of 1.0/ 1000 catheter days for all complications. CONCLUSIONS: The VectorFlow catheter produced safe, effective hemodialysis with Kt/V ≥1.5. A single catheter occlusion occurred and a low rate of infection was seen. Results support the hypothesis that the VectorFlow design reduces thrombogenic risk during clinical performance.

Intraosseous vascular access is safe, effective and costs less than central venous catheters for patients in the hospital setting.

PURPOSE: Central venous catheters (CVCs) are often placed to resuscitate unstable emergency department (ED) patients. In an observational study, we assessed intraosseous (IO) vascular access in the hospital, and compared results to published experiences with CVC placement. 
 METHODS: Patients who would typically receive a CVC were considered for the study. Vascular access was gained using a powered IO device. Data collection included placement success, placement time, ease-of-use, satisfaction with flow rates, complications and subsequent CVC placement. 
 RESULTS: A total of 105 cases were studied from six centers. Mean age was 48.0±28.0 years and 53% were men; 85% of the patients were medical cases, and 53% were in cardiac/respiratory arrest. Of those, 48% returned to spontaneous circulation. A total of 94% of placements were successful on the first attempt. Mean time to IO access was 103.6±96.2 seconds. There was one serious complication - a lower extremity compartment syndrome. IO access costs $100/patient.
 CONCLUSIONS: The data revealed faster and more successful IO catheter placement than reported for CVCs, few complications and high user satisfaction. For simple placements, cost savings for IO access vs. CVCs was $195/procedure. If 20% of the 3.5 million CVCs placed annually were replaced with IO catheters, cost savings could approach $650 million/year. We conclude that IO access in place of CVCs delivers high value in terms of being a safe, fast and effective mode of vascular access for patients in the hospital setting, with potentially substantial cost savings. These data indicate that IO access is a cost effective and viable alternative to problematic CVC lines.

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 prospective randomised study of a rotary powered device (OnControl) for bone marrow aspiration and biopsy.

INTRODUCTION: Bone marrow aspiration and biopsy is an invasive procedure associated with morbidity and mortality risk. We compared a powered bone marrow aspiration and biopsy device to the traditional method by relatively assessing pain scores, procedure times, biopsy capture rates, quality of material retrieved, and safety and operator satisfaction. METHODS: Two large academic medical centres participated in this trial. Patients were randomised to have procedures carried out using the powered system or the manual technique. A visual analogue scale pain score was recorded immediately following skin puncture and once again at the end of the procedure for each patient. Procedure time was measured from skin puncture to core specimen acquisition. Pathologic assessment of 30 randomised samples was carried out. Operator satisfaction with devices was measured on a scale of 0-10, with 10 as the highest rating. RESULTS: Five operators from two sites enrolled 50 patients (powered, n=25; manual, n=25). Groups were evenly matched, with no significant differences in the means for age, weight and height. The powered system was superior to the manual system with respect to patient perceived pain from needle insertion (2.6±2.0 vs 4.1±2.5, p=0.022) and procedural time (100.0±72.8 s vs 224.1±79.0 s, p<0.001). Overall pain scores at the end of both procedures were comparable (3.2±2.2 vs 3.8±3.0, p=0.438). No complications were observed in either arm of the study. Blinded pathologic analysis of the specimens retrieved revealed that cores obtained using the powered system were longer and wider than those obtained using the manual technique (25.4±12.3 mm² vs 11.9±5.6 mm², p=0.001). For marrow aspiration, no difference was seen between groups for clot/particle spicules or smear spicules. Operator assessment favoured the use of the powered device. CONCLUSIONS: Results of this trial suggest that the use of a powered bone marrow biopsy device significantly reduces needle insertion pain and procedural time when compared to a manual technique. The superior size and overall quality of core specimens retrieved by the powered device provides more material for pathologic evaluation, thereby increasing diagnostic yield and reducing the need for repeat procedures.

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.

The OnControl bone marrow biopsy technique is superior to the standard manual technique for hematologists-in-training: a prospective, randomized comparison.

The purpose of this study was to compare a novel bone marrow device with the standard marrow needle in a prospective, randomized study in a teaching hospital employing hematologists-in-training. The new device, the OnControl Bone Marrow (OBM) Biopsy System, utilizes a battery-powered drill to insert the needle. Fifty-four bone marrows (27 standard and 27 OBM) were performed by 11 fellows under the observation and supervision of 3 attending hematologists and 1 research technologist. The primary endpoint of the study, the mean length of the marrow biopsy specimens, a surrogate for marrow quality, was determined by a pathologist in a blinded manner. The mean length of the marrow biopsy specimens was significantly longer (56%) for the OBM group (15.3 mm) than for the standard bone marrow (SBM) group (9.8 mm), P<0.003. An objectively determined secondary endpoint; mean procedure time, skin-to-skin; also favored the OBM group (175 s) versus the SBM group (292 s), P<0.007. Several subjective secondary endpoints also favored the OBM group. Only minor adverse events were encountered in the OBM and SBM study groups. It was concluded that bone marrow procedures (BMPs) performed by hematologists-in-training were significantly faster and superior in quality when performed with the OBM compared to the SBM. These data suggest that the OBM may be considered a new standard of care for adult hematology patients. OBM also appears to be a superior method for training hematology fellows.

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.

The use of multiple intraosseous catheters in combat casualty resuscitation.

During the current military engagements in Iraq and Afghanistan, establishing intravenous (IV) access for resuscitation of critically injured casualties remains a persistent challenge. Intraosseous (IO) access has emerged as a viable alternative in resuscitation. In this case report, a 19 year-old male soldier was severely wounded by a roadside bomb in Iraq. Given the heavy initial blood loss, anatomic location of the injuries and gross wound contamination, peripheral IV access could not be established. Instead, multiple IO catheters were used to initiate fluid resuscitation prior to transfer to a combat support hospital. To our knowledge, this is the first report of such extensive usage of IO catheters. Multiple IO catheters can be placed rapidly and safely and may help solve the challenge of establishing vascular access for resuscitation of critically injured casualties.

Cost effectiveness of kinetic therapy in preventing nosocomial lower respiratory tract infections in patients suffering from trauma.

Studies show that kinetic therapy (KT) reduces the incidence of early pneumonia and other complications, and shortens hospital length of stay. Using decision-tree software in a retrospective analysis of one investigator's clinical data, the authors sought to determine if KT is cost effective for preventing nosocomial pneumonia and other complications in patients with critical illnesses. This analysis revealed that KT yielded 202 fewer infections per 1,000 patients suffering trauma--a cost savings of $6,695 per patient compared with standard care. On this basis, they conclude that prophylactic KT is cost effective and should be considered for at-risk patients in the critical care setting.