Intra-Osseous Access in Difficult Vascular Access Cases

Study Overview
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Brief Summary
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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.

Official Title
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Intra-Osseous Access in Difficult Vascular Access Cases

Conditions
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Hemodynamic Instability

Intervention / Treatment
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* Device: Intraosseous venous access
* Device: Peripheral venous access


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Patient with hemodynamic failure defined as: systolic blood pressure (SBP) < 90 mm Hg (2 measures) or cardiac arrest or 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Interventional study with randomisation (1:1)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intraosseous venous access<br>intraosseous venous access | Device: Intraosseous venous access<br>* Immediate placement of humeral intra-osseous venous access (after a first failed attempt of peripheral venous access)<br>|
| Active Comparator: peripheral venous access<br>Limiting use of intraosseous access (intraosseous access possible after 3 attempts of peripheral venous access) | Device: Peripheral venous access<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | • In patients with cardiac arrest: Return of spontaneous circulation (ROSC), an average of 1 hour | 
| 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 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. | • In patients with hemodynamic failure: Reach a systolic blood pressure correction, an average of 1 hour | 
| 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 requiring endo-tracheal intubation: time required to achieve intubation. | • In patients requiring endo-tracheal intubation: Achieve intubation, an average of 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize the conditions for implementation of the procedure, depending on the strategy used. | Failure to place the catheter defined by the absence of infusion or by withdrawal of the catheter within one minute after the opening of the infusion | 1 minute | 
| To characterize the conditions for implementation of the procedure, depending on the strategy used. | Number of punctures | In patients with cardiac arrest: Return of spontaneous circulation (ROSC), an average of 1 hour | 
| To characterize the conditions for implementation of the procedure, depending on the strategy used. | Number of punctures | In patients with hemodynamic failure: Reach a systolic blood pressure correction, an average of 1 hour | 
| To characterize the conditions for implementation of the procedure, depending on the strategy used. | Number of sites treated | In patients requiring endo-tracheal intubation: Achieve intubation, an average of 1 hour | 
| To characterize the conditions for implementation of the procedure, depending on the strategy used. | Use of alternative routes (central venous access, oral, rectal, subcutaneous, intramuscular - and intra-osseous in the control group) | In patients with cardiac arrest: Return of spontaneous circulation (ROSC). In patients with hemodynamic failure: Reach a systolic blood pressure correction. In patients requiring endo-tracheal intubation: Achieve intubation | 
| To characterize the conditions for implementation of the procedure, depending on the strategy used. | Use of alternative routes (central venous access, oral, rectal, subcutaneous, intramuscular - and intra-osseous in the control group) | In patients with cardiac arrest: Return of spontaneous circulation (ROSC), an average of 1 hour | 
| To characterize the conditions for implementation of the procedure, depending on the strategy used. | Use of alternative routes (central venous access, oral, rectal, subcutaneous, intramuscular - and intra-osseous in the control group) | In patients with hemodynamic failure: Reach a systolic blood pressure correction, an average of 1 hour | 
| To characterize the conditions for implementation of the procedure, depending on the strategy used. | Use of assistance tools (ultrasound, infra-red) | In patients requiring endo-tracheal intubation: Achieve intubation, an average of 1 hour | 
| To characterize the conditions for implementation of the procedure, depending on the strategy used. | Delays in placing venous access | In patients with cardiac arrest: Return of spontaneous circulation (ROSC). In patients with hemodynamic failure: Reach a systolic blood pressure correction. In patients requiring endo-tracheal intubation: Achieve intubation | 
| To characterize the conditions for implementation of the procedure, depending on the strategy used. | Delays in placing venous access | In patients with cardiac arrest: Return of spontaneous circulation (ROSC), an average of 1 hour | 
| To characterize the conditions for implementation of the procedure, depending on the strategy used. | Delays in placing venous access | In patients with hemodynamic failure: Reach a systolic blood pressure correction, an average of 1 hour | 
| To characterize the conditions for implementation of the procedure, depending on the strategy used. | Delays for administration of drugs/solutes | In patients with cardiac arrest: Return of spontaneous circulation (ROSC), an average of 1 hour | 
| To characterize the conditions for implementation of the procedure, depending on the strategy used. | Delays for administration of drugs/solutes | In patients with hemodynamic failure: Reach a systolic blood pressure correction, an average of 1 hour | 
| To characterize the conditions for implementation of the procedure, depending on the strategy used. | Delays for administration of drugs/solutes | In patients requiring endo-tracheal intubation: Achieve intubation, an average of 1 hour | 
| To determine the length of stay in hospital | Length of stay in hospital | Days 28 | 
| To evaluate morbidity depending on the strategy used. | Non-functional venous | In patients with cardiac arrest: Return of spontaneous circulation (ROSC), an average of 1 hour | 
| To evaluate morbidity depending on the strategy used. | Non-functional venous | In patients with hemodynamic failure: Reach a systolic blood pressure correction, an average of 1 hour | 
| To evaluate morbidity depending on the strategy used. | Non-functional venous | IIn patients requiring endo-tracheal intubation: Achieve intubation, In patients with hemodynamic failure: Reach a systolic blood pressure correction, an average of 1 hour | 
| To evaluate morbidity depending on the strategy used. | Local complication (subcutaneous diffusion, hematoma, pain...) | Days 28 | 
| To evaluate morbidity depending on the strategy used. | Need to replace the venous access | Hours 72 | 
| To evaluate mortality depending on the strategy used. | Death | Days 28 | 
| To evaluate the patient's feedback, depending on the strategy used. | Evaluation of procedural pain on an analog visual scale, EVA, simple verbal scale, EVS or numerical scale, EN (from 0 to 100, the higher is the worse) In the case of patient with cardiac arrest, only the operator satisfaction will be assessed. | Immediately after the insertion of the catheter (opening of the perfusion) and on arrival at the hospital, In patients with hemodynamic failure: Reach a systolic blood pressure correction, an average of 1 hour | 
| To evaluate the team's feedback, depending on the strategy used. | Operator satisfaction assessed (EVA, EVS or EN) after the placement of the catheter and on arrival at the hospital (from 0 to 100, the higher is the worse). | Immediately after the insertion of the catheter (opening of the perfusion) and on arrival at the hospital, In patients with hemodynamic failure: Reach a systolic blood pressure correction, an average of 1 hour |