Alternative Intra Osseous Devices: randomised controlled trial comparing three intraosseous methods

ISRCTN	ISRCTN85744812
DOI	https://doi.org/10.1186/ISRCTN85744812
Secondary identifying numbers	N/A

Submission date: 28/12/2006
Registration date: 28/12/2006
Last edited: 07/03/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr I B Schipper
Scientific

Erasmus Medical Center
Trauma Center ZWN
Room Z-9.15
P.O. Box 2040
Rotterdam
3000 CA
Netherlands

Phone	+31 (0)10 463 5034
Email	i.schipper@erasmusmc.nl

Study information

Study design	Randomised, controlled, parallel group, single blinded study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study acronym	AIOD
Study objectives	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 complications compared with the traditional bone needle Jamshidi.
Ethics approval(s)	Approval received from the Medical Ethical review board, Erasmus Medical Centre, Rotterdam, The Netherlands. The approval was completed at 15th June 2006 with reference number MEC-2006-109.
Health condition(s) or problem(s) studied	Severe injury, life threatening
Intervention	The intervention consists of the application of a randomised instraosseous needle: 1. In people over 14 years: BIG versus FAST versus conventional bone needle 2. In children more than one and less than 14 years: BIG versus conventional bone needle
Intervention type	Device
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)
Primary outcome measure	1. Primary endpoint: aspiration of bone marrow upon successful placement of a bone needle. 2. Primary parameter is time required for successful placement.
Secondary outcome measures	Secondary endpoint: Complications encoured using an intraosseous device Secondary parameters: 1. Adverse events 2. Success rate (%) 3. User friendliness (Visual Analogue Scale [VAS]) 4. Pain scored by the patient (VAS)
Overall study start date	21/06/2006
Completion date	20/06/2008

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Not Specified
Target number of participants	150
Key inclusion criteria	1. Patients in acute life threatening situations, requiring assistance of a mobile medical team 2. Intravascular medical or fluid resuscitation is necessary and intravascular access cannot be obtained after two attempts
Key exclusion criteria	1. Children under the age of one year 2. Patients with suspected sternumanomaly (only FAST1)
Date of first enrolment	21/06/2006
Date of final enrolment	20/06/2008

Locations

Countries of recruitment

Netherlands

Study participating centre

Erasmus Medical Center

Rotterdam
3000 CA
Netherlands

Sponsor information

Erasmus Medical Center (The Netherlands)
Hospital/treatment centre

Trauma Center ZWN
P.O. Box 2040
Amsterdam
3000 CA
Netherlands

Website	http://www.erasmusmc.nl/
"ROR"	https://ror.org/018906e22

Funders

Funder type

Other

Medirisk (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan