Alternative IntraOsseous Devices Randomised controlled trial comparing 3 intraosseous methods.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON23528

Enrollment

150

Registered

2006-07-17

Start date

2006-06-21

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

severely injured patients

Interventions

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.

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. Childeren under the age of 1 year; 2. Patients with suspected sternumanomaly (only FAST1).

Design outcomes

Primary

Measure	Time frame
Primary endpoint: aspiration of bone marrow upon succesfull placement of a bone needle. Primary parameter is: time required for successful placement.	—

Secondary

Measure	Time frame
Secundary endpoint: complications of the bone needle used. Secundary parameters are: complications, success rates, user friendliness, pain encountered by the patient.	—

Contacts

Public ContactI.B. Schipper

Erasmus Medical Center, Trauma Center ZWN, room Z-9.15, P.O. Box 2040

i.schipper@erasmusmc.nl+31 (0)10 4635034

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)