Disclosures. Implications for Peripheral Venous Access. Consultant & Participant in Research for Becton-Dickinson. The Science of Power Injection

Transcription

1 The Science of Power Injection Implications for Peripheral Venous Access Gregory J. Schears, MD Rochester, MN Disclosures Consultant & Participant in Research for Becton-Dickinson

2 Objectives Review the pathophysiology of extravasation induced tissue injury with an emphasis on contrast media Discuss the science of power injection and its impact on extravasation Provide new insights into the cause of extravasation and a technology that may help reduce this complication IV Infusion Complications Extravasation

3 Definitions Extravasation - Is the inadvertent administration of a vesicant solution or medication into the surrounding tissues. Vesicant Is a solution or medication that causes the formation of blisters with subsequent sloughing of tissues occurring from tissue necrosis. Infusion Nursing: An Evidence Based Approach, 3 rd Edition, Saunders, Chapter V, 471-2, 2010 Access Related Cause A dislodged venous catheter or cannula Leaking of the medication or contrast media at injection site Rupture of the wall of the vessel Metal needles, large-gauge catheters Inadequate securement Undesirable site choice Wilson, BG, Radiologic Tech, 2011; 83 (1): Sauerland, C, et.al., Oncology Nurs Forum, 33 (6) 2006, Incidence-Extravasation Published reports from 0.01 to 6.5% For Contrast Media (CM) to 1.3% 39 Million Contrast enhanced CT-2007 CM extravasations 15, ,000 Schulmeister, L, Seminars in Oncology Nursing, 2007; 23: Sum, W, Ridley, LJ, Australasian Radiology, 2006; 50: CT Market Summary Report - March 2008", IMV Medical Information Division, Inc., pg. IV-57

4 Presentation Wilson, BG, Radiologic Tech, 2011; 83 (1): Presentation Ranges from swelling and minor skin irritation and pain to severe skin and tissue necrosis, ulceration, vascular and nerve compromise to limb and life threatening compartment syndrome The severity of damage is directly related to the type, concentration and volume of the extravasated material Infusion Nursing: An Evidence Based Approach, 3 rd Edition, Saunders, Chapter V, 471-2, 2010

5 Vesicant Extravasation: Myths and Realities by D.M. Boyle and C. Engelking, 1995, Oncology Nursing Forum, 22, p. 60. Vesicants Cause tissue injury when infused outside the vascular space when: Direct or indirect toxicity (Chemo) ph < 5 or > 9 (Dopamine, Acyclovir) Osmolality > 600 mosm / L (PPN, D 25 W) Earhart, A, McMahan, P, JIN, (2) V E S I C A N T S Sauerland, C, et.al., Oncology Nurs Forum, 33 (6) 2006,

6 V E S I C A N T S Sauerland, C, et.al., Oncology Nurs Forum, 33 (6) 2006, Risk Factors Device Related Metal needles, large gauge catheters Inadequate catheter securement Undesirable IV site location Agent Related Vesicant Volume infiltrated Drug concentration Repeated use of same vein Sauerland, C, et.al., Oncology Nurs Forum, 33 (6) 2006, Risk Factors - continued Patient Related Age (very young or old) Impaired communication Compromised circulation Altered sensory perception Fear, anxiety, cultural barriers, meds Clinician Related Lack of knowledge Lack of IV skills Interruptions and distractions Sauerland, C, et.al., Oncology Nurs Forum, 33 (6) 2006,

7 Risk Factors - continued The Technique Use of Power Injector Less optimal injection sites including lower limb and small distal veins Large volume of contrast High osmolar contrast medium Bellin, MF, et.al., Eur Radiol, 2002; 12: Compartment Syndrome Compartment Syndrome Most feared physiology of extravasation injury Most common severe injury associated with contrast media extravasation Occurs when swelling and increased pressure within a compartment compromise structures located within the compartment (blood vessels, nerves, muscles, and tendons) Wilson, BG, Radiologic Tech, 2011; 83 (1): 63-77

8 Compartment Syndrome Wilson, BG, Radiologic Tech, 2011; 83 (1): Compartment Syndrome Wilson, BG, Radiologic Tech, 2011; 83 (1): Compartment Syndrome Wilson, BG, Radiologic Tech, 2011; 83 (1): 63-77

9 Belzunegui et al. Scandinavian Journal of Trauma, Resuscitation and Emergency Medicine 2011, 19:9 Belzunegui et al. Scandinavian Journal of Trauma, Resuscitation and Emergency Medicine 2011, 19:9

10 Amaral J, Traubic J, BenDavid G, et al. Safety of Power Injector Use in Children as Measured by Incidence of Extravasation. AJR 2006; 187: Bellin M, Jakobsen J, Tomassin I, et al. Contrast Medium Extravasation Injury: Guidelines for Prevention and Management. Eur Radiol, 2002;12: Belzunegui T, Louis C, Torrededia L, et al. Extravasation of Radiographic Contrast Material and Compartment Syndrome in the Hand: a case report. Scand J Trauma, 2011;19(9):1-4 Birnbaum B, Nelson R, Chezmar J, et al. Extravasation Detection Accessory: Clinical Evaluation in 500 Patients. Radiology 1999; 212: Bui K, Horner J, Herts B, et al. Intravenous Iodinated Contrast Agents: Risks and Problematic Situations. Clev Clin J Med, 2007;74(5): Cohan R, Ellis J, Garner W. Extravasation of Radiographic Contrast Material:Recognition, Prevention, and Treatment. Conventional Contrast Iodine provides vascular imaging contrast Higher [iodine] yields better opacification Higher [iodine] increases risk of AE Most contrast agents now nonionic The osmolality of nonionic contrast agents relates to its extravasation toxicity Osmolality is a measure of the number of particles dissolved in 1 kg of water (mosm/l) Costa, N, JIN 2004; 27(5): Earhart, A, McMahan, P, JIN, (2)

11 MRI Gadolinium-based contrast used in MRIs Typically lower extravasation toxicity than conventional contrast Lower volumes typically used ~ 14 ml Often hand injected Agents have high osmolality which can cause tissue injury Earhart, A, McMahan, P, JIN, (2) Runge, VM, et.al., Invest Radiol 2002;37: M R I C O N T R A S T Runge, VM, et.al., Invest Radiol 2002;37: Rickham, R, et.al. Onc Nursing Forum, 33 (6) , 2006

12 Prevention Knowledge of vesicant potential Reducing / awareness of known risks Fresh, optimally functioning catheter Monitoring the site during Power Injection Educated, aware patient Prevention Impedance monitor which detects changes Four true positives, 484 true negatives Twelve false positives = 2.4% Technology is expensive Birnbaum, BA, Radiology; 1999, 212: Power Injection

13 Science of Power Injection Science of Power Injection Infusion Induced Catheter Movement (IICM) is the movement of the catheter caused by the jet of fluid flowing from its distal end. Science of Power Injection 10 ml Saline Pulsed 10 ml Saline Pushed

14 Science of Power Injection Fluid Velocity & Thrust Fluid Velocity = V = Q/A Where: Q = Flow rate A = Crosssectional area of lumen Diffusics Ovine Study

15 Purpose This study will compared the power injection induced angular deflection catheter motion of the BD Nexiva Diffusics 22 and 24ga product to 20, 22, and 24ga BD Insyte Autoguard 22 ga. BD Nexiva Diffusics 22 ga. BD Insyte Autoguard Diffusics Insyte

16 Hypothesis The additional catheter fenestrations will reduce catheter motion in vivo compared to standard. Reduction in catheter motion will help reduce catheter associated complications.

17 Methods Sheep model used as a human replicate for insertional forces and catheter performance IACUC approved protocol, PIVs inserted with sheep under general anesthesia Catheter motion monitored using IR suite fluoroscopy and video recorded Ten ~ 150lb fully grown adult sheep Insertion sites shaved and depilator applied Methods Front and back legs used equally IV insertion alternated between IAG and Diffusics IV placed, secured with transparent dressing and allowed to in-dwell 6 min before power injection Omnipaque 350 Contrast Media used at room temperature 24 ga injected at 3 or 4 ml/sec for 10 sec 22 ga injected at 4 or 6.5 ml/sec for 10 sec Methods Each catheter only 2 injections, the second higher than the first Steel ball in field as measurement standard Camera at 90 degrees of injection A total of 480 power injections performed Data analyzed for catheter motion, backout and any adverse events

18 Methods Steel Ball for Standardized Vessel Size Measurement Methods Results Frequency Histogram of Vessel Diameter, mm Normal Variable Included V essel Diameter, mm Excluded V ein Diameters, mm Mean StDev N Vessel Diameter, mm

19 24 ga BD Insyte at 3 ml/sec 24 ga BD Diffusics at 3 ml/sec 22 ga BD Insyte at 6.5 ml/sec

20 22 ga BD Nexiva Diffusics at 6.5 ml/sec 24 ga BD Insyte at 3 ml/sec-extrav 24 ga BD Insyte at 3 ml/sec-extrav

21 24 ga BD Nexiva Diffusics at 3 ml/sec 22 ga BD Insyte 6.5 ml/sec, extrav 22 ga BD Nexiva Diffusics at 6.5 ml/sec

22 24 ga std 4 ml/sec, Int & Ext 22 ga std 6.5 ml/sec, Int & Ext Results Flow Rate N N Mean 95% Conf. Median Product Gauge (ml/s) Analysis Excluded Deflection Interval Deflectio n SD Min Max Diffusics (1.27, 2.46) Diffusics (3.58, 6.24) Diffusics (2.22, 3.84) Diffusics (5.23, 11.58) IAG (4.19, 7.54) IAG (4.05, 6.95)

23 Predicted Percent of Back-outs vs. Deflection Angle Percentage of Whip/Flip as a Function of Deflection Angle

24 Predicted % of Extravasation as a Function of Deflection Angle Results Flow Rate Percent 95% Upper 95% Upper Comparisons (ml/s) Difference Bound Criteria < Criteria Diffusics 24ga - IAG 22ga 4 ml/s 8.0% 58.8% 181.8% TRUE Diffusics 22ga - IAG 20ga 6.5 ml/s -17.3% 32.4% 170.6% TRUE Results Flow Rate Diffusics 24ga IAG 24ga Event (ml/s) Yes No Percent Yes No Percent Catheter Backout Observed % % Catheter Backout Observed % % Extravasation Observed % % Extravasation Observed % % Catheter Flip/Whip % %

25 Results Comparisons Percent Difference 95% Upper Bound Adjusted P- Value Diffusics 24ga 3ml/s vs IAG 24ga 3ml/s -67.3% -50.2% < Diffusics 24ga 4ml/s vs IAG 24ga 4ml/s -72.5% -57.9% < Diffusics 22ga 4ml/s vs IAG 22ga 4ml/s -48.7% -0.60% 0.05 Catheter Securement & Extravasation

26 Results Using a transparent dressing for both IAG and Diffusics catheter stabilization there were no episodes of catheter hub movement in this acute model. A prior study with only tape in the same model securement demonstrated catheter hub movement. Conclusions Catheter movement without hub movement was responsible for extravasation injury during power injection in the animal model IAG demonstrated IICM as has been seen before with PICCs under clinically relevant injection rates The angle of deflection predicted the likelihood of extravasation Transparent dressing was adequate securement to eliminate hub movement

27 Conclusions Diffusics catheters demonstrated noninferior angular deflection even at one size below standard IAG catheters Diffusics catheters showed significantly less movement and were less likely to cause extravasation during power injection Diffusics may help reduce / prevent patient complications associated with power injection or even routine use. References

28 Amaral J, Traubic J, BenDavid G, et al. Safety of Power Injector Use in Children as Measured by Incidence of Extravasation. AJR 2006; 187: Bellin M, Jakobsen J, Tomassin I, et al. Contrast Medium Extravasation Injury: Guidelines for Prevention and Management. Eur Radiol, 2002;12: Belloni B, Andres C. Extravasation of Peripherally Administered Parenteral Nutrition. N Engl J Med, 2011;364:10 Belzunegui T, Louis C, Torrededia L, et al. Extravasation of Radiographic Contrast Material and Compartment Syndrome in the Hand: a case report. Scand J Trauma, 2011;19(9):1-4 Birnbaum B, Nelson R, Chezmar J, et al. Extravasation Detection Accessory: Clinical Evaluation in 500 Patients. Radiology 1999; 212: Bui K, Horner J, Herts B, et al. Intravenous Iodinated Contrast Agents: Risks and Problematic Situations. Clev Clin J Med, 2007;74(5): Camp-Sorrell D. Developing Extravasation Protocols and Monitoring Outcomes. J Intraven Nurs, 1998;21(4): Cohan R, Ellis J, Garner W. Extravasation of Radiographic Contrast Material:Recognition, Prevention, and Treatment. Radiology 1996; 200: Costa N. Understanding Contrast Media. J Infus Nurs, 2004;27(5): Earhart A, McMahon P. Vascular Access and Contrast Media. INS, 2011;34(2): Namasivayam S, Kalra M, Torres W, et al. Adverse Reactions to Intravenous Iodinated Contrast Media: An Update. Curr Probl Diagn Radiol, 2006;July/Aug: Runge V, Dickey K, Williams N, et al. Local Tissue Toxicity in Response to Extravascular Extravasaion of Magnetic Resonance Contrast Media. Investigative Radiology 2002;37(7): Schulmeister L. Extravasation Management: Clinical Update. Semin Oncol Nurs, 2007;23: Sinan T, Al-Khawari H, Chishti F, et al. Contrast Media Extravasation: Manual Versus Power Injector. Med Princ Pract, 2005;14: Sum W, Ridley LJ. Recognition and Management of Contrast Media Extravasation. Australasian Radiology, 2006;50: Wickham R, Engelking C, Sauerland C, et al. Vesicant Extravasation Prat I: Mechanisms, Pathogenesis, and Nursing Care to Reduce Risk. ONF, 2006;33(6): Wickham R, Engelking C, Sauerland C, et al. Vesicant Extravasation Prat II: Evidence-Based Management and Continuing Controversies. ONF, 2006;33(6):