Intra-Osseous Access in Difficult Vascular Access Cases (IODA)

Assistance Publique - Hôpitaux de Paris

Status: Terminated

Conditions: Hemodynamic Instability

Treatments: Device: Intraosseous venous access; Device: Peripheral venous access

Study type: Interventional

Funder types: Other

Identifiers

NCT05708833

P170918J

Details and patient eligibility

About

Thousands of peripheral venous accesses are inserted every day all over the world. Some of them, such as those inserted in emergency and / or in critical patients, are absolutely vital. In the particular context of prehospital care, the rate of failure of the first attempt to insert a peripheral venous access has been evaluated at 25%. Success rates of successive attempts were about 75%. Nevertheless, the final success rate is close to 100%.

Failure or delay in obtaining venous access can be life-threatening. Thus, alternatives to peripheral venous access have been proposed including intraosseous route recently made easier by the development of an automated puncture device (EZ-IO®), but still rarely used, especially on conscious patient.

Currently, the place of intraosseous venous access in critical patients is not determined.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adult patient, in prehospital setting, without venous access and after failure of the first attempt to place a peripheral venous access by a senior operator (doctor or nurse) AND

2. Patient with hemodynamic failure defined as:

   • systolic blood pressure (SBP) < 90 mm Hg (2 measures) or
   • cardiac arrest or

3. Any situation requiring intubation

Exclusion criteria

• 1- Age < 18 years

  2- Venous access already available

  3- Known contra-indications to intraosseous access (i.e. bilateral lesions):

• Bone fracture

• Skin infection

• Osteoporosis

• Osteomyelitis

• Local burns

• Recent failed intraosseous attempt

• Prior surgery

• Compartment syndrome

• Every other local specific situations

  4- Pregnancy woman

  5- Patient with no national health or universal plan affiliation coverage

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3 participants in 2 patient groups

intraosseous venous access

Experimental group

Description:

intraosseous venous access

Treatment:

Device: Intraosseous venous access

peripheral venous access

Active Comparator group

Description:

Limiting use of intraosseous access (intraosseous access possible after 3 attempts of peripheral venous access)

Treatment:

Device: Peripheral venous access