EZ-IO Presentation 1

Advances In Intraosseous Vascular Access
Dr.med.univ. Fadel Soliman

10.01.2007 Copyright Vidacare 2007 Fadel Soliman, Dr.med.univ. 1
Presentation Agenda
Overview (Clinical Need, IO History, Anatomy & Physiology) State of the Art 2006 (FDA & CE Cleared IO Devices) IO Research Specific Patient Experiences
Prospective Multi-Center Trial Comparative Studies
The Benefits of IO Access to Emergency Medicine

The Worldwide Clinical Need

10.01.2007
Copyright Vidacare 2007 Fadel Soliman, Dr.med.univ.
6.4 Million Patients In The United States

Emergency Medical Services
Patients that Need IVs - 11,850,000
68%
8,058,000 Easy
17% 15%
Difficult 2,014,000
IV problems= 3,792,000 patients

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Impossible 1,778,000
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6.4 Million Patients In The United States

Emergency Department
Patients that Need IVs - 8,276,000
67%
5,586,000 Easy
10%
Difficult 1,862,000
23%
IV problems= 2,2,000 patients

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Impossible 828,000
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Central Line Complications

Mechanical
Pneumothorax Arterial puncture with hematoma
Thrombotic
15% of patients develop catheter related thrombus Causes catheter blockage
Infection
Incidence suggests need for caution
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History of intraosseous access

IO has endured for more than 65 years as a safe and effective alternative to IV Reports of over 4,000 adult patients treated during the 1940s and 50s IO Access became a lost art for 40 years because no civilian EMS service existed to utilize the technique Re-discovered in 1985 by James Orlowski MD while on a trip to India Established standard of care in Pediatric Advanced Life Support Recently adopted standard of care in American Heart Association and European Resuscitation Council guideline revisions
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AHA and ERC Guidelines

IO should be early second line choice for vascular access following 2-3 attempts at a peripheral IV in adults and first line choice for pediatrics The ET tube is no longer recommended for drug delivery Central lines are discouraged
CDC report indicates 9% infection rate with central lines in US Infections associated with 10% mortality and cost of $25k/infection Central line placement causes unnecessary delay in drug delivery in resuscitation setting
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Anatomy of intraosseous access
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10.01.2007 11 Thousands of small veinsCopyright Vidacare 2007 Fadel Soliman,to the central circulation lead from the medullary space T430 RevA Dr.med.univ.
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Lets Put Pain in Prospective
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Intraosseous access: Is it painful?
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Why Lidocaine? Anesthetic vs. Analgesic

Pain associated with IO infusion is related to stimulation of pressure sensors (nerve fibers) in the medullary space Lidocaine inhibits stimulation of those sensors and the propagation of signals along the efferent pain fibers Pain management with analgesic agents can cause systemic effects and may not eliminate local pain Analgesics alter the perception of pain while anesthetics block sensation
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The Right Amount of Lidocaine

2 % (preservative and Epinephrine free) Lidocaine - given intraosseously (IO) - has been shown to offer effective local anesthesia in most alert patients
As with any drug always consult the pharmaceutical DFUs prior to use Ensure patient does not have an allergy to lidocaine
Adult patients: give in 1ml increments Pediatric dosage 0.025 ml/kg (2% lidocaine) increments Prime the EZ-Connect extension set with Lidocaine Infuse Lidocaine slowly (over 30 - 60 seconds) Allow 15-30 seconds for anesthetic effect Repeat as needed for pain management
10.01.2007 Medical
DirectorCopyright authorize appropriate dosage range 16 must Vidacare 2007 Fadel Soliman,
Dr.med.univ.
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The Right Amount of Pressure

The pressure in the medullary space is approximately 1/3 of the patients arterial pressure Pressurizing fluids for infusion is required to obtain maximum flow rates For aggressive fluid resuscitation a rapid infuser may increase flow rates
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Infuse fluids with pressure
Regulate fluid delivery for ALL patients and take patient condition into account with amounts delivered
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The Right Flush

The IO space is filled with a thick fibrin mesh The medullary space must be pressure flushed to obtain maximum flow rates A minimum of 10ccs is required for initial bolus Flush must overcome initial resistance felt with bolus administration More than one flush may be required to achieve maximum flow rate
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Syringe FLUSH catheter

Prime and use extension set Reminder: Patients responsive to pain may require 2% preservative free Lidocaine intraosseously PRIOR to syringe flush Some patients may require multiple syringe flushes
No Flush = No Flow
10.01.2007 Syringe
FLUSH Copyright Vidacare 2007 Fadel Soliman, sterile solution catheter with 10 ml of a
Dr.med.univ.
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Pressure and Flow Rates

With a pressure bag or infusion pump, IO flow rates are similar to IV
Tibial similar to a 20 gauge catheter Humeral similar to a 16 gauge catheter
Flow rates for infusions given through an IO with a 300 mm pressure infuser 50 cc 100cc/ min Unit of blood in approximately 15 - 30 minutes
Syringe bolus infusions can be completed in seconds Initial rapid 10 cc saline bolus dramatically increases IO flow rates
NO FLUSH = NO FLOW
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 What Dose? IO and IV doses are identical Flow Rates (A rapid 10 cc saline bolus must be given prior to any infusion): To maintain optimal IO flow, pressure of 300 mm Hg should be applied to the infusion bag or the pump Lab Testing: 5 cc of blood can be aspirated from an IO device and placed into a heparin-coated syringe for standard laboratory testing
The Right Site

Site selection is dependent upon: Absence of contraindications Accessibility of the site Ability to monitor and secure the site Desired flow rates
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Pediatric EZ-IO Insertion

Pediatric insertion requires a gentle grip and a soft touch One size does not fit all Consider tissue depth in needle selection Be cautious of driver recoil release the trigger when you feel the pop or give Always use a stabilizer on newborns and infants
3- 39 kg usage
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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

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IO is the Answer
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Contraindications for EZ-IO Access

Fracture (targeted bone) Previous orthopedic procedures near insertion site
Prosthetic Limb or joint
IO within past 24 hours (targeted bone) Infection at the insertion site Inability to locate landmarks or excessive tissue
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Potential Complications for most IO devices

Extravasation Compartment syndrome Dislodgement Fracture Failure (Device or user in origin) Pain Infection Retrospective Analysis in pediatrics and adults suggests that infection rates are < 0.6%
Precise Insertion & Placement of the IO Device is Imperative for Success
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FDA & CE Cleared IO Devices

Cook/Jamshidi / Illinois Sternal Primarily used for pediatrics FAST - 1 Designed for adult sternum B.I.G. Bone Injection Gun Projects a needle set into adult tibia EZ-IO Powers a hollow needle set into the medullary space
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Manually Inserted
Manually inserted hand held infusion needles have been available for years Mostly used for infants because their bones are soft
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COOK
JAMSHIDI
FAST-1 (PYNG)
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The Bone Injection Gun (BIG)

Adult B.I.G - 15G Pediatric B.I.G - 18G
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A New Intraosseous Device
Approved for adult and pediatric use

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s5
The Right Needle

Selection based on: Weight Range (PD 3-39kg , AD 40kg or LD excessive tissue) Soft tissue depth judged by calibrating your finger Visualization of the 5mm mark after penetration of the skin Special situations for use of the LD needle
Excessive soft tissue Excessive muscle tissue Edema
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Slide 39 s5 Need a fatter baby or a muscle builder. The image should communicate deep tissue not cuteness.
sdralle, 1/27/2009
EZ-IO PD 15 mm Needle Set

5 mm mark
EZ-IO AD 25 mm Needle Set
EZ-IO LD 45 mm Needle Set
Length 10.01.2007
and color are theVidacare 2007 Fadel Soliman, Copyright only differences between Needle Sets40
Dr.med.univ.
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Put Stylets Where They Belong . . .
EZ-IO LD sharps protector
Portable sharps protector

10.01.2007
in approved bio-hazard sharps containers Copyright Vidacare 2007 Fadel Soliman,

Dr.med.univ.
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How IO Benefits Patients and Providers

Saves time Saves lives Decreases risk of complications Saves Money Improves Clinical Excellence Easy to use (Intuitive) Easy to maintain (competency and equipment)
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IO drug delivery during CPR Kramer C. et al

Study Objective: To compare - IO bolus vs IV bolus
for vascular delivery of drugs during experimental CPR
Subjects: Ten swine (2530 kg), anesthetized, instrumented & subjected to cardiac arrest and CPR.
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Protocol
Cardiac Arrest KCI

No treatment: 8 minutes CPR: 2 minutes
Sternum INJECT
Tibia Series -1 IV Series -2
Bolus Evans Blue/Epinephrine

0.2 mg/ml
Bolus ICG/Epinephrine
0.2 mg/ml
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Appearance time
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Peak Concentrations
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How effective is IO during CPR?
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EZ-IO Removal
Maintain a 90 degree angle Rotate the syringe clockwise
Gently pull
Maintain 90 degree angle, Rotate clockwise and gently Pull

The reality of intraosseous access
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The 5 Rights of the EZ-IO

1. 2. 3. 4. 5. The Right Needle The Right Site The Right Amount of Lidocaine The Right Flush The Right Amount of Pressure
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Slide 52 s6 Picture needs to change

sdralle, 1/27/2009
Cleaning & Disinfecting

Wipe clean with moistened cloth Spray with anti-microbial solution Momentarily depress trigger several times during cleaning Clean around drive shaft with cotton applicator check to ensure nothing has attached to the magnetic tip Wipe dry Inspect driver and return to case or replace trigger guard
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Copyright Vidacare DRIVER AT DO NOT SUBMERGE 2007 Fadel Soliman, ANY TIME Dr.med.univ.
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Thank You!
fadel.soliman@vidacare.com
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Questions
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Advances In Intraosseous Vascular Access

Dr.med.univ. Fadel Soliman

The Benefits of IO Access to Emergency Medicine

The Worldwide Clinical Need

Copyright Vidacare 2007 Fadel Soliman, Dr.med.univ.

6.4 Million Patients In The United States

IV problems= 3,792,000 patients

Copyright Vidacare 2007 Fadel Soliman, Dr.med.univ.

6.4 Million Patients In The United States

IV problems= 2,2,000 patients

Copyright Vidacare 2007 Fadel Soliman, Dr.med.univ.

Central Line Complications

Copyright Vidacare 2007 Fadel Soliman, Dr.med.univ.

History of intraosseous access

Copyright Vidacare 2007 Fadel Soliman, Dr.med.univ.

AHA and ERC Guidelines

Copyright Vidacare 2007 Fadel Soliman, Dr.med.univ.

Anatomy of intraosseous access

Copyright Vidacare 2007 Fadel Soliman, Dr.med.univ.

Anatomy of intraosseous access

Anatomy of intraosseous access

Copyright Vidacare 2007 Fadel Soliman, Dr.med.univ.

Lets Put Pain in Prospective

Copyright Vidacare 2007 Fadel Soliman, Dr.med.univ.

Intraosseous access: Is it painful?

Copyright Vidacare 2007 Fadel Soliman, Dr.med.univ.

Why Lidocaine? Anesthetic vs. Analgesic

Copyright Vidacare 2007 Fadel Soliman, Dr.med.univ.

The Right Amount of Lidocaine

The Right Amount of Pressure

Copyright Vidacare 2007 Fadel Soliman, Dr.med.univ.

Infuse fluids with pressure

Copyright Vidacare 2007 Fadel Soliman, Dr.med.univ.

The Right Flush

Copyright Vidacare 2007 Fadel Soliman, Dr.med.univ.

Syringe FLUSH catheter

Pressure and Flow Rates

The Right Site

Copyright Vidacare 2007 Fadel Soliman, Dr.med.univ.

Copyright Vidacare 2007 Fadel Soliman, Dr.med.univ.

Copyright Vidacare 2007 Fadel Soliman, Dr.med.univ.

Pediatric EZ-IO Insertion

Copyright Vidacare 2007 Fadel Soliman, Dr.med.univ.

Copyright Vidacare 2007 Fadel Soliman, Dr.med.univ.

IV access is often difficult or impossible in these situations

Copyright Vidacare 2007 Fadel Soliman, Dr.med.univ.

Contraindications for EZ-IO Access

Copyright Vidacare 2007 Fadel Soliman, Dr.med.univ.

Potential Complications for most IO devices

Copyright Vidacare 2007 Fadel Soliman, Dr.med.univ.

FDA & CE Cleared IO Devices

Copyright Vidacare 2007 Fadel Soliman, Dr.med.univ.

Copyright Vidacare 2007 Fadel Soliman, Dr.med.univ.

Copyright Vidacare 2007 Fadel Soliman, Dr.med.univ.

The Bone Injection Gun (BIG)

Copyright Vidacare 2007 Fadel Soliman, Dr.med.univ.

A New Intraosseous Device

Approved for adult and pediatric use

Copyright Vidacare 2007 Fadel Soliman, Dr.med.univ.

The Right Needle

Copyright Vidacare 2007 Fadel Soliman, Dr.med.univ.

EZ-IO PD 15 mm Needle Set

EZ-IO AD 25 mm Needle Set

EZ-IO LD 45 mm Needle Set