Alternative Intra Osseous Devices: randomised controlled trial comparing three intraosseous methods
| ISRCTN | ISRCTN85744812 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85744812 |
| Protocol serial number | N/A |
| Sponsor | Erasmus Medical Center (The Netherlands) |
| Funder | Medirisk (The Netherlands) |
- 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
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 |
|---|---|
| i.schipper@erasmusmc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, controlled, parallel group, single blinded study |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure(s) |
1. Primary endpoint: aspiration of bone marrow upon successful placement of a bone needle. |
| Key secondary outcome measure(s) |
Secondary endpoint: Complications encoured using an intraosseous device |
| Completion date | 20/06/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Not Specified |
| Target sample size at registration | 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
3000 CA
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
