Alternative IntraOsseous Infusion
Randomised controlled trial comparing 3 intraosseous methods

Within the Netherlands there is a well-established network of trauma care. In
emergency situations outside the hospital ambulance teams provide help. Upon
their request a mobile medical team (MMT) may assist. This is primarily the
case in life-threatening situations that instantly require additional medical
support.
In order to be able to provide adequate fluid resuscitation and to administer
medication, generating access to the patients* circulation is a prerequisite
prior to stabilizing the patient. The Gold standard for accessing the
circulation is placing an intravenous infusion. In certain situations, however,
this may not be possible. For instance in patients with hypothermia, patients
in shock, but also in (small) children, achieving intravenous access may not be
possible. The best alternative in such cases is the intraosseous bone needle.
This is a hollow metal tube that is placed into the bone marrow of e.g. the
lower limb. Upon proper placement of the bone needle, an infusion system will
be connected to it, providing a means to admit fluid and medication. These
substances reach the vasculair circulation via the bone marrow, which itself is
abundantly vascularized. The bone needle, also called intraosseous device, is
applied both in adults and children.
The bone needle may be applied both in children as in adults. In adult, it may
be hard to place the bone needle due to composition of the bone. In former
times, a screw-tipped bone needle was used by the MMT to create an entry to the
circulation. This device, however, has been taken from the market in 2005.
Several novel intraosseous methods have been developed in order to properly
place bone needles. According to the suppliers these new methods are faster and
easier compared with the conventional bone needle.
In the current study, different types of bone needles will be compared. These
include a conventional needle (Jamshidi), the Bone Injection Gun (BIG) and the
First Access for Shock and Trauma (FAST).

Both in emergency departments and in prehospital services (ambulances and MMTs)
effort is being done to find a fast alternative for the screw-tipped bone
needle that has the least amount of risk and complications.
The aim of this study is to analyse whether or not it is possible to created a
fast, reliable intraosseous entrance using the BIG and/or FAST bone needles,
with less complication compared with the traditional bone needles. The data
achieved will enable us to pinpoint the bets of intraosseous device that will
subsequently replace the screw-tipped bone needle.
The outcome of the study will impact emergency care both within Emergency
Departments as well as ambulances and MMTs.

In order to objectively compare the three different devices, a randomized study
will be performed, using clinical results, complication rate, and user
friendliness as outcome measures.
For adults, 3 types of devices will be used. The conventional bone needle will
be applied by rotation and pressure. The second device, BIG, contains a
pressurized spring, that "launches" the needle into the intramedullar space.
The FAST also contains a pressurized spring, but has been developed for use at
the sternum site only. As opposed to the other devices, the FAST cannot be used
in small children. The other devices can be applied at multiple locations. A
separate study in children will be performed, comparing the BIG and the
conventional bone needle.
Based upon a power calculation it was decided to test 30 bone needles of each
type (3 types in adults, 2 in children). This makes 150 in total.
Critical care nurses of the MMT will place the needles and will collect data
such as time required for proper placement and complications encountered. All
data will be processed at the Trauma Centre South West Netherlands.

The intervention consists of the application of a randomized bone needle.
- In people >= 14 years: BIG vs FAST vs conventional bone needle.
- In children <= 13 jaar: BIG vs conventional bone needle.

Inclusion criteria:
Patients with suspected sternumanomaly; large skin defects, skin infection or
fracture at the site of the insertion location; Two or more placed bone needles

Exclusion criteria:
Patients in acute life threatening situations, requiring assistance of a mobile
medical team. These patients need to be reanimated, or placement of an
intravenous infusion has been insuccessful in two attempts.

This examination will not encompass addition risks for the patients.
For the patient no additional testing will be done due to this study. The
physician removing the bone needle will be asked to fill out a short
questionnaire.