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Review of Current Intraosseous Infusion Devices

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1 Review of Current Intraosseous Infusion Devices
4/23/2017 Review of Current Intraosseous Infusion Devices VidaCare

2 Lecture Outline Review relevant anatomy, indications, & contraindications Present background reasons for interest in expanding use of intraosseous (IO) line insertion in adults Describe the insertion procedure for the 4 types of currently approved IO devices

3 4/23/2017 Relevant Anatomy Thousands of small veins lead from the bone medullary space to the general circulation VidaCare

4 4/23/2017 Anatomy of long bones VidaCare

5 4/23/2017 VidaCare

6 Intraosseous (IO) Pressure and Flow Rates
4/23/2017 Intraosseous (IO) Pressure and Flow Rates With a pressure bag or IV pump, Intraosseous (IO) flow rates are similar to IV’s through a 21-gauge needle. Rate of infusion that can be given IO under 300 mm pressure : 2 to 50 cc / min (average 10 cc / min) 120 to 3,000 cc / hour (average 600 cc / hour) Unit of blood in about 30 minutes Rate of infusion that can be given IO under 1 meter gravity : 1 to 15 cc / min (average 4 cc / min) Unit of blood in about 60 minutes Unit dose injections can be given in seconds (5cc in 3 sec) Rapid 10 cc syringe bolus dramatically increases IO flow rates If no flush ---- there may be no flow ! VidaCare

7 4/23/2017 Intrinsic IO Pressure VidaCare

8 IO Infusion of Medication
4/23/2017 IO Infusion of Medication Which Drugs can be given ? Any medications that can be safely injected into a peripheral IV can likewise be safely injected IO Caution with cytotoxic drugs and hypertonic saline What Dose ? IO medication doses are the same as those for IV injection Flow rates (Rapid 10 cc bolus must be given first) : To maintain optimal flow, pressure of 300 mm Hg must be applied to the infusion bag or the pump Testing : 5 cc of blood can be aspirated from an IO device and placed into a heparin-coated syringe for standard laboratory testing VidaCare

9 Potential IO Complications
4/23/2017 Potential IO Complications Extravasation (leakage) Dislodgement Compartment syndrome Fracture of the bone Failure Pain (more about this on next slide) Infection Experience in thousands of children and reports on 4,000 adults show the infection rate to be less than 0.6 % and those infections are usually not serious (can be treated as outpatients with removal of device) Mortality from above complications : None VidaCare

10 Pain from IO Insertion 85 % of IO patients will be unconscious
4/23/2017 Pain from IO Insertion 85 % of IO patients will be unconscious For them, pain is not an issue For the conscious patient : pain is an issue Pain related to insertion of needle : Minimal May numb the skin and periosteum with local xylocaine Pain related to infusion of meds / fluids (visceral pressure) Numb the vessels by injecting xylocaine 10 mg IO Psychological anxiety : “You are going to do what ?” Talk to your patient first VidaCare

11 Related to IO Insertion
4/23/2017 Two Kinds of Pain Related to IO Insertion VidaCare

12 IO Contraindications Local Infection
4/23/2017 IO Contraindications Local Infection Major trauma to extremity : fractures in same limb Prosthesis Recent (24 hours) previous IO Vascular compromise : diabetic leg (relative contraindication) Absence of anatomical landmarks Osteogenesis Imperfecta VidaCare

13 IV access is often difficult or impossible in these situations.
4/23/2017 IO Indications Cardiac arrest Status epilepticus Shock / Trauma Arrhythmia Dehydration Burns Drug overdose DKA (diabetic) End stage renal disease Stroke Myocardial infarction Coma Head Injury Anaphylaxis Congestive heart failure Dialysis Emphysema Respiratory arrest Hemophiliac crisis Sickle Cell crisis Pediatric shock Chest pain IV access is often difficult or impossible in these situations. IO is the Answer ! VidaCare

14 Anatomic Sites for IO Insertion
Just below and medial to tibial tubercle (preferred site for both children and adults) Lower anterior femur (for children) Alternative sites for adults : Ankle medial malleolus Anterior humeral head Sternum Patella

15 Current IO State-of-the-Art
4/23/2017 Current IO State-of-the-Art Universally taught as a core skill to : Paramedics Emergency physicians Emergency and Pediatric Nurses Used as a rescue IV access port in pediatrics Current Standard of Care for children So far only used sporadically in adults New groundswell of interest for adults in past year New ACLS, PALS, ATLS, ENPC guidelines recommend adult IO for difficult vascular access VidaCare

16 The IO Paradigm is Changing
4/23/2017 The IO Paradigm is Changing No adult devices : New adult IO devices have been FDA approved. Fear : 15 years experience in children has dispelled the fear of penetrating someone’s bone. Infection : Infection has not been a problem. Pain : Pain is controllable. Difficult : New devices make the procedure easier than starting an IV. No Support : Strong support from military, EMS, ER, ACLS. Now the “Standard of Care” : PALS, ACLS, Military . VidaCare

17 American Heart Association : 2003 ACLS Principles & Practice
4/23/2017 New IO Mandate “The use of IO devices is a promising technique to establish emergency access in adult patients” . American Heart Association : 2003 ACLS Principles & Practice VidaCare

18 Military Interest in IO’s
4/23/2017 Military Interest in IO’s VidaCare

19 IV’s Are Difficult in Military Situations
4/23/2017 IV’s Are Difficult in Military Situations Battlefield conditions Darkness with use of night vision equipment Hot or cold environments Stressful : bullets flying overhead Ratio of medics to troops : 1 to 40 or higher Medic has to carry everything he needs in his rucksack (50 kg limit) Training & experience Medics are generally well trained But have little opportunity for experience until actually needed Is civilian prehospital trauma care any different ? IV’s are just as difficult Many of the same factors apply VidaCare

20 For 10 casualties it could take 2 hours to start IV’s
4/23/2017 Unnecessary Deaths Acute hemorrhage is the major cause of Battlefield Mortality 50 % are killed immediately 50 % die within 1 hour of injury Improvement in care requires Control of bleeding Rapid IV administration of blood & fluids Most serious casualties go into shock Veins collapse making IV access difficult Average time for a medic to start an IV = 12 minutes Average success rate in battlefield conditions = 30 % For 10 casualties it could take 2 hours to start IV’s VidaCare

21 National Academy of Sciences Institute of Medicine, 1999
4/23/2017 National Academy of Sciences Institute of Medicine, 1999 VidaCare

22 F.D.A. Approved IO Devices
4/23/2017 F.D.A. Approved IO Devices Jamshidi / Illinois Sternal / Cook (manually pushed in) needles Mostly used for pediatrics F.A.S.T. Pyng (Bed of Nails) Designed for adult sternum Manually inserts 10 needles at once B.I.G. Bone Injection Gun (Nail Gun) Shoots a needle into adult tibia and other bones EZ-IO (Battery Powered Drill) by VidaCare Company Powers a hollow drill (Catheter) into the medullary space VidaCare

23 Manually Inserted IO Needles
4/23/2017 Manually Inserted IO Needles Manually inserted hand held infusion needles have been available for years. Mostly used for infants because their bones are soft. VidaCare

24 4/23/2017 PYNG (F.A.S.T.) IO Device VidaCare

25 F.A.S.T. Insertion Procedure
4/23/2017 F.A.S.T. Insertion Procedure Do not attempt to use the F.A.S.T. 1 system unless you have been formally trained, evaluated, and authorized to perform this procedure ! VidaCare

26 F.A.S.T. Insertion Procedure
4/23/2017 Undo or cut shirt to expose sternum. Prepare the area of the manubrium with the iodine and alcohol swabs included in the package : wipe the area 1” below the sternal notch. VidaCare

27 F.A.S.T. Insertion Procedure
4/23/2017 Remove top half of backing labeled 1. Place index finger in patient’s sternal notch ; the locating finger must be perpendicular to the manubrium. Align Patch notch with patient’s sternal notch. VidaCare

28 F.A.S.T. Insertion Procedure
4/23/2017 Secure first half of the patch by pressing firmly downward, engaging the adhesive. Reaching under the Patch, remove backing labeled 2 and press Patch to skin. VidaCare

29 F.A.S.T. Insertion Procedure
4/23/2017 Verify location : check that the locating notch matches the sternal notch and that the Target Zone is over the manubrium. This is critical for safe and effective placement of the device. VidaCare

30 F.A.S.T. Insertion Procedure
4/23/2017 Remove Sharps Cap from the introducer ; the clear plastic Sharp Cap can be removed by slightly twisting and pulling away. Place the bone probe cluster in the target zone with its long axis PERPENDICULAR (90 DEGREES) TO THE SKIN. Ensure needle cluster is within the target zone. VidaCare

31 F.A.S.T. Insertion Procedure
4/23/2017 Press the Introducer into the target zone with firm and increasing force, until a distinct release of the Introducer handle is heard and felt. The force must be applied in line with the long axis of the Introducer ; the forearm and elbow must be in line with Introducer’s axis. After release pull straight back to remove the Introducer. 14 15 VidaCare

32 F.A.S.T. Insertion Procedure
4/23/2017 Attach the right-angle female connector to the infusion tube. 16. 17 Attach syringe to straight female connector and withdraw marrow into the Infusion Tube to verify successful placement. Remove and discard syringe. 18 VidaCare

33 F.A.S.T. Insertion Procedure
4/23/2017 19. Place the protector dome over the patch and press down firmly to engage the velcro fastening. VidaCare

34 F.A.S.T. Removal Procedure
4/23/2017 F.A.S.T. Removal Procedure Remove the Protector Dome from the Target Patch. Disconnect the Infusion Tube from the right angle female connector on the Patch. Do not pull on the infusion tube to remove it ! 20 21 VidaCare

35 F.A.S.T. Removal Procedure (Continued)
4/23/2017 F.A.S.T. Removal Procedure (Continued) 1 Insert the Remover into the Infusion Tube : keep the Infusion Tube straight out (90 degrees) from the patient. Advance the remover till you hear or feel it enter the threads in the proximal tip of the infusion tube. Turn the remover clockwise until it stops. Pull straight out on the remover to remove the infusion tube. 2 3 4 VidaCare

36 The B.I.G™ IO Device Pediatric B.I.G : 18 Gauge Adult B.I.G : 15 Gauge
4/23/2017 The B.I.G™ IO Device Pediatric B.I.G : 18 Gauge FDA Approved Adult B.I.G : 15 Gauge FDA Approved VidaCare

37 B.I.G. Technique of Insertion
4/23/2017 B.I.G. Technique of Insertion Use a povidone iodine tincture sponge to clean the selected site for injection. Position the front of the B.I.G™ at the selected site, holding and pushing firmly on the rear of the instrument. VidaCare

38 B.I.G. Insertion Sequence
4/23/2017 B.I.G. Insertion Sequence 1 . 4 2 5 3 VidaCare

39 B.I.G. Technique of Insertion
4/23/2017 B.I.G. Technique of Insertion Position the BIG with one hand to the site and pull out the Safety Latch with the other hand. VidaCare

40 B.I.G. Technique of insertion
4/23/2017 B.I.G. Technique of insertion Trigger the BIG at 90º to the surface. VidaCare

41 B.I.G. Technique of Insertion
4/23/2017 B.I.G. Technique of Insertion Remove the BIG. Pull out the stylet (trocar). VidaCare

42 Technique of insertion
4/23/2017 Technique of insertion Connect IV Set with a stopcock and flush with 1 mg / kg for IO local anesthetics. Fix the cannula with the Safety Latch. VidaCare

43 The “EZ-IO” Drill Device
4/23/2017 The “EZ-IO” Drill Device “Making difficult IV access a thing of the past” Jointly owned and developed by The University of Texas Health Science Center & VidaCare Corporation VidaCare

44 Univ. of Texas in San Antonio
4/23/2017 Univ. of Texas in San Antonio . Dr. Larry Miller who developed the EZ-IO device VidaCare

45 “A kinder - gentler way”
4/23/2017 EZ-IO Description Establishes IO access simply & automatically Uses a hollow drill to enter the bone Small battery powered driver implants the needle Enables immediate access for all drugs and fluids Provides safe and easy IO access for adults “A kinder - gentler way” VidaCare

46 EZ-IO needle and sheath
4/23/2017 Final Design EZ-IO needle and sheath The EZ-IO drill VidaCare

47 Use of the EZ IO drill in a pediatric patient

48 EZ IO needle placed in tibia

49 Connector tubing for the EZ IO

50 How Adult EZ-IO Infusion Benefits Emergency Medicine
4/23/2017 How Adult EZ-IO Infusion Benefits Emergency Medicine Saves time Takes less than 10 seconds IV’s take an average of 8 minutes One provider can treat multiple patients (Mass casualties) Faster transport (less time on scene) Improves throughput time (in the emergency department) Can be started en route (less scene time) Allows provider to handle other problems : i.e. airway, meds VidaCare

51 How Adult EZ-IO Infusion Benefits Emergency Medicine (cont.)
4/23/2017 How Adult EZ-IO Infusion Benefits Emergency Medicine (cont.) Easy to Teach Short learning curve Technique can be taught in less than one hour Easy to remember (skill retention) High success rate builds confidence Huge benefit for first responders with limited critical care exposure VidaCare

52 How Adult EZ-IO Infusion Benefits Emergency Medicine (cont.)
4/23/2017 How Adult EZ-IO Infusion Benefits Emergency Medicine (cont.) Easy to Use Large target area High success rate (better than 97 %) High retention of skill level Intuitive procedure Vastly easier than starting IV’s May be used by Basic EMT’s VidaCare

53 How the EZ-IO Device Benefits Emergency Medicine
4/23/2017 How the EZ-IO Device Benefits Emergency Medicine Easy to Maintain Rugged : designed for the emergency environment Long shelf life Replaceable AA batteries Operates at wide temperature range Easy to clean Small storage space required Replacement parts sent overnight (24 hour support) VidaCare

54 IO Summary Venous access in shock is often difficult or impossible
4/23/2017 IO Summary Venous access in shock is often difficult or impossible Thousands die because of lack of IV fluids & drugs. IO has been used successfully for 65 years The science behind it is solid ; its’ rationale is sound. Inside the bone is a huge non-collapsible vein Functions well in shock states. Last 15 years in kids demonstrates IO to be Safe & Effective Serious side effects are very rare (less than 1%). IO has saved many children’s lives. Currently IO is vastly underutilized in adults IO should be considered first line treatment in serious illnesses for children and adults . VidaCare

55 4/23/2017 IO Summary We are witnessing a major paradigm shift in IO use for adults : “With adult-IO, you no longer have to worry about time consuming and often exasperating IV access. You can now concentrate on the more important aspects of airway management, arrhythmias, fluid resuscitation, wound management and scene time” Larry Miller M.D . VidaCare


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