Comparison of Two Mechanical Intraosseous Infusion Devices: A Randomized Crossover Trial

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Comparison of Two Mechanical Intraosseous
Infusion Devices A Randomized Crossover Trial

• Shavit I 1, Hoffmann Y 1, Galbraith R 2, Waisman
  Y 3

• Meyer Children's Hospital, Rambam Health Care
  Campus, Haifa, Israel
• Alberta Children's Hospital, Calgary, AB, Canada
• Schneider Children's Medical Center, Petah
  Tiqva, Israel

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American Heart Association 2005 PALS guidelines

• Intraosseuos (IO) access is recommended if
  vascular access is not achieved rapidly in any
  infant or child for whom intravenous (IV) drugs
  or fluids are urgently required
• In cardiac arrest immediate IO access is
  recommended if no other IV access is already in
  place
• Endotracheal Drug Administration? Any vascular
  access, IO or IV, is preferable

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IO Techniques approved for children

• IO needle
• Spring-loaded IO infusion device
• (BIG - Bone Injection Gun, Waismed Ltd., NY,
  USA)
• Battery-powered IO infusion drill
  (EZIO,
  Vidacare, San Antonio TX, USA)

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Establishing IO access

• It is a rarely used emergency skill which might
  be difficult to perform (the success rate of the
  manual technique is experience dependent)
• The new devices (EZIO BIG) increase the options
  available for IO access
• There have been no studies specifically comparing
  the EZIO and the BIG

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Study objective

• To compare the success rate of one attempt and
  the ease-of-use of the BIG and the EZIO
• Study hypothesis
• There is no difference in success rate and
  ease-of-use between the two devices

Study design
Randomized crossover trial Sequence of device
insertion was randomized to either BIG-first or
EZIO-first
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Bone Model

• Previous studies demonstrated that turkey bone
• have similarity to the long bones of children
• Uncooked bones of the lower leg of a turkey
  (drumsticks)
• stripped of their overlying meat were used as the
  bone
• model
• .

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Outcome measures

• Primary outcome measure (test method)
• Successful attempt
• Visualization of flow emerging from the IO cavity
  without extravasation of
• fluid around the drilled hole.
• Unsuccessful attempt
• Fluid did not emerge from the bone marrow or
  extravasated around the
• drilled hole
• Non-conclusive attempt
• Fluid emerged from other hole/s within the bone
  (bone defect)

Each insertion attempt was recorded on video
(only the bone and the IV line tubing were
filmed). Study investigators blinded to the group
allocation, reviewed the video films
independently, rated each procedure as
successful, unsuccessful or non-conclusive, and
recorded any technical complication
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• Secondary outcome measures
• 1. Ease of use.
• A 5-point Likert Scale.
• "the device is easy to use"
• 1-strongly disagree, 2-disagree, 3-neither agree
  nor disagree, 4-agree,
• 5-strongly agree.
• 2. Which of the two is your first choice device
  (BIG or EZIO)?

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Study instruments

• BIG - a small semi-automatic, disposable,
  spring-loaded device with a
• trigger. Pediatric version indicated for children
  younger than 12 y/o,
• contains an 18-gauge needle, and has an
  adjustable insertion depth of
• between 0.5 cm and 1.5 cm
• EZIO - a semi-automatic system that consists of a
  multiple-use,
• rechargeable, battery-powered driver with an
  integrated hollow drill-
• tipped needle. The Pediatric version utilized a
  15-gauge, 1.5 cm long
• needle for children from 3 to 39 kg.

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Study procedure

• Prior to IO insertion
  
• Participants watched 2 standardized
  educational videos on the use and the techniques
  of insertion of the BIG and the EZIO, and a
  10-minute demonstration on the IO model with each
  device.

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IO insertion
A
A
A
A
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Results

• 29 participants
• BIG-first group - 15, Mean age (y) -20.3, 615
  female to male ratio.
• EZIO-first group 14, Mean age (y) - 19.8, 414
  female to male ratio
• 
  

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• Unsuccessful attempts and technical problems
• BIG (10 unsuccessful attempts)
• 6 - stuck stylet cases (the stylet was stuck
  within the needle and could not be removed)
• 2 - failure to insert the needle
• 2 - extravasation of fluid around the drilled
  hole.
• EZIO (1 unsuccessful attempt)
• 1 - extravasation of fluid around the drilled
  hole.
• 2 non-conclusive attempts were recorded with each
  device. All 4
• repeated attempts were successful
• Bending or breaking of needles were not recorded
  with either device

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Conclusions

• Paramedic students instructed in how to insert
  two
• mechanical IO infusion devices into turkey bones
  had higher
• success rates with the EZIO than with the BIG,
  and
• Indicated the EZIO as the preferred device

Limitations
- Small sample size - Non-human bone model
(applicability of our data to a real leg is
unclear) - Success rates of only one attempt was
recorded (we were limited in the number of
needles supplied to us by the two manufacturers)
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THANK YOU
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Disclosure

• The Investigators received supplies from
  the manufacturers, but not funding.
• Waismed Ltd (Persys Medical Division
  of PERSYS Group), and Vidacare corporation
  supplied the mechanical IO infusion devices and
  the needles, but had no role in the design of the
  study in the collection, analysis, and
  interpretation of the data in the writing of the
  report or in the decision to submit the paper
  for publication.
• Study investigators do not have an
  affiliation (financial or otherwise) with any
  commercial organization that may have a direct or
  indirect connection to the content of this
  presentation.