search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Alternative IntraOsseous Devices Randomised controlled trial comparing 3 intraosseous methods.


- candidate number2171
- NTR NumberNTR732
- ISRCTNISRCTN85744812
- Date ISRCTN created28-dec-2006
- date ISRCTN requested18-dec-2006
- Date Registered NTR17-jul-2006
- Secondary IDsN/A 
- Public TitleAlternative IntraOsseous Devices Randomised controlled trial comparing 3 intraosseous methods.
- Scientific TitleAlternative IntraOsseous Devices Randomised controlled trial comparing 3 intraosseous methods.
- ACRONYMAIOD
- hypothesisThe 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.
- Healt Condition(s) or Problem(s) studiedSevere injury
- Inclusion criteria1. Patients in acute life threatening situations, requiring assistance of a mobile medical team; 2. Intravasculair medical or fluid resuscitation is necessary and intravasculair access cannot be obtained after two attempts.
- Exclusion criteria1. Childeren under the age of 1 year; 2. Patients with suspected sternumanomaly (only FAST1).
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type[default]
- Studytypeintervention
- planned startdate 21-jun-2006
- planned closingdate20-jun-2008
- Target number of participants150
- InterventionsThe intervention consists of the application of a randomized instraosseous needle. 1. In people = > 14 years: BIG vs FAST vs conventional bone needle; 2. In children 1> and < 14 jaar: BIG vs conventional bone needle.
- Primary outcomePrimary endpoint: aspiration of bone marrow upon succesfull placement of a bone needle. Primary parameter is: time required for successful placement.
- Secondary outcomeSecundary endpoint: complications of the bone needle used. Secundary parameters are: complications, success rates, user friendliness, pain encountered by the patient.
- Timepoints
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDr. I.B. Schipper
- CONTACT for SCIENTIFIC QUERIES K.A. Hartholt
- Sponsor/Initiator Erasmus Medical Center, Trauma Center ZWN
- Funding
(Source(s) of Monetary or Material Support)
Medirisk
- PublicationsHartholt KA, Van Lieshout EMM, Thies WC, Patka P, Schipper IB. Intraosseous devices: a randomized controlled trial comparing three intraosseous devices. Prehosp Emerg Care 2010;14(1)6-13.
- Brief summaryBoth in emergency departments and in prehospital services effort is being done to find a fast entrance to the circulation. If an intravenous access is not possible or it takes too long, intraosseous infusion is a good alternative both in adults and children. In the last few years, a few new intraosseous needles had been developed. The aim of this study is to analyze the time required to obtain a successful intraosseous entrance using the Bone Injection-Gun, Jamshidi and/or FAST1 intraosseous needles. The inserted needles will be compared on time to successful placement, adverse events and complications. The data achieved will enable us to pinpoint the best of intraosseous devices that will subsequently replace the currently used screw-tipped bone needle.
- Main changes (audit trail)
- RECORD17-jul-2006 - 15-jan-2012


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl