No registrations found.
ID
Source
Brief title
Health condition
severely injured patients
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint: aspiration of bone marrow upon succesfull placement of a bone needle.
Primary parameter is: time required for successful placement.
Secondary outcome
Secundary endpoint: complications of the bone needle used.
Secundary parameters are: complications, success rates, user friendliness, pain encountered by the patient.
Background summary
Both 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.
Study objective
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.
Intervention
The 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.
P.O. Box 2040
I.B. Schipper
Rotterdam 3000 CA
The Netherlands
+31 (0)10 4635034
i.schipper@erasmusmc.nl
P.O. Box 2040
I.B. Schipper
Rotterdam 3000 CA
The Netherlands
+31 (0)10 4635034
i.schipper@erasmusmc.nl
Inclusion criteria
1. 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 criteria
1. Childeren under the age of 1 year;
2. Patients with suspected sternumanomaly (only FAST1).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL722 |
| NTR-old | NTR732 |
| Other | : N/A |
| ISRCTN | ISRCTN85744812 |
Summary results
IB. Intraosseous devices: a randomized controlled trial comparing three
intraosseous devices. Prehosp Emerg Care 2010;14(1)6-13.