Intra-Osseous Access in Difficult Vascular Access Cases

Assistance Publique - Hôpitaux de Paris3 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Hemodynamic Instability

Interventions

Peripheral venous accessDEVICE

Looking for peripheral venous access, changing the site of puncture, the caliber of the catheter and/or the operator and/or assistance tools (ultrasound, infra-red guidance...) and/or using another route (oral, rectal, subcutaneous, intramuscular route and central venous access)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

To demonstrate that the early recourse to the intraosseous route, from the first failure, makes it possible to obtain more quickly the correction of the failure of critical patient managed in prehospital setting.

• In patients with cardiac arrest: Time required for a return of spontaneous circulation (ROSC). Only the first ROSC will be considered.

Time frame: • In patients with cardiac arrest: Return of spontaneous circulation (ROSC), an average of 1 hour

• In patients with hemodynamic failure: delay to reach a systolic blood pressure correction, i.e. systolic blood pressure \> 90 mm Hg. Systolic blood pressure will be assessed every 5 minutes after the placement of the intravenous line. Two consecutive measures are required to reach the end-point. In the cases where continuous invasive blood pressure monitoring will be available, systolic blood pressure \> 90 mm Hg \> 1 minute will be required.

Time frame: • In patients with hemodynamic failure: Reach a systolic blood pressure correction, an average of 1 hour

• In patients requiring endo-tracheal intubation: time required to achieve intubation.

Time frame: • In patients requiring endo-tracheal intubation: Achieve intubation, an average of 1 hour