IODA: Intra-Osseous Access in Difficult Vascular Access Cases
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: intraosseous venous access intraosseous venous access |
Device: Intraosseous venous access
Immediate placement of humeral intra-osseous venous access (after a first failed attempt of peripheral venous access)
|
| Active Comparator: peripheral venous access Limiting use of intraosseous access (intraosseous access possible after 3 attempts of peripheral venous access) |
Device: Peripheral venous access
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)
|
Outcome Measures
Primary Outcome Measures
- 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: Return of spontaneous circulation (ROSC), an average of 1 hour]
• In patients with cardiac arrest: Time required for a return of spontaneous circulation (ROSC). Only the first ROSC will be considered.
- 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: Reach a systolic blood pressure correction, 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.
- 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: Achieve intubation, an average of 1 hour]
• In patients requiring endo-tracheal intubation: time required to achieve intubation.
Secondary Outcome Measures
- To characterize the conditions for implementation of the procedure, depending on the strategy used. [1 minute]
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
- To characterize the conditions for implementation of the procedure, depending on the strategy used. [In patients with cardiac arrest: Return of spontaneous circulation (ROSC), an average of 1 hour]
Number of punctures
- To characterize the conditions for implementation of the procedure, depending on the strategy used. [In patients with hemodynamic failure: Reach a systolic blood pressure correction, an average of 1 hour]
Number of punctures
- To characterize the conditions for implementation of the procedure, depending on the strategy used. [In patients requiring endo-tracheal intubation: Achieve intubation, an average of 1 hour]
Number of sites treated
- To characterize the conditions for implementation of the procedure, depending on the strategy used. [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]
Use of alternative routes (central venous access, oral, rectal, subcutaneous, intramuscular - and intra-osseous in the control group)
- To characterize the conditions for implementation of the procedure, depending on the strategy used. [In patients with cardiac arrest: Return of spontaneous circulation (ROSC), an average of 1 hour]
Use of alternative routes (central venous access, oral, rectal, subcutaneous, intramuscular - and intra-osseous in the control group)
- To characterize the conditions for implementation of the procedure, depending on the strategy used. [In patients with hemodynamic failure: Reach a systolic blood pressure correction, an average of 1 hour]
Use of alternative routes (central venous access, oral, rectal, subcutaneous, intramuscular - and intra-osseous in the control group)
- To characterize the conditions for implementation of the procedure, depending on the strategy used. [In patients requiring endo-tracheal intubation: Achieve intubation, an average of 1 hour]
Use of assistance tools (ultrasound, infra-red)
- To characterize the conditions for implementation of the procedure, depending on the strategy used. [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]
Delays in placing venous access
- To characterize the conditions for implementation of the procedure, depending on the strategy used. [In patients with cardiac arrest: Return of spontaneous circulation (ROSC), an average of 1 hour]
Delays in placing venous access
- To characterize the conditions for implementation of the procedure, depending on the strategy used. [In patients with hemodynamic failure: Reach a systolic blood pressure correction, an average of 1 hour]
Delays in placing venous access
- To characterize the conditions for implementation of the procedure, depending on the strategy used. [In patients with cardiac arrest: Return of spontaneous circulation (ROSC), an average of 1 hour]
Delays for administration of drugs/solutes
- To characterize the conditions for implementation of the procedure, depending on the strategy used. [In patients with hemodynamic failure: Reach a systolic blood pressure correction, an average of 1 hour]
Delays for administration of drugs/solutes
- To characterize the conditions for implementation of the procedure, depending on the strategy used. [In patients requiring endo-tracheal intubation: Achieve intubation, an average of 1 hour]
Delays for administration of drugs/solutes
- To determine the length of stay in hospital [Days 28]
Length of stay in hospital
- To evaluate morbidity depending on the strategy used. [In patients with cardiac arrest: Return of spontaneous circulation (ROSC), an average of 1 hour]
Non-functional venous
- To evaluate morbidity depending on the strategy used. [In patients with hemodynamic failure: Reach a systolic blood pressure correction, an average of 1 hour]
Non-functional venous
- To evaluate morbidity depending on the strategy used. [IIn patients requiring endo-tracheal intubation: Achieve intubation, In patients with hemodynamic failure: Reach a systolic blood pressure correction, an average of 1 hour]
Non-functional venous
- To evaluate morbidity depending on the strategy used. [Days 28]
Local complication (subcutaneous diffusion, hematoma, pain...)
- To evaluate morbidity depending on the strategy used. [Hours 72]
Need to replace the venous access
- To evaluate mortality depending on the strategy used. [Days 28]
Death
- To evaluate the patient's feedback, depending on the strategy used. [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]
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.
- To evaluate the team's feedback, depending on the strategy used. [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]
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).
Eligibility Criteria
Criteria
Inclusion Criteria:
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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
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Patient with hemodynamic failure defined as:
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systolic blood pressure (SBP) < 90 mm Hg (2 measures) or
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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):
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Bone fracture
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Skin infection
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Osteoporosis
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Osteomyelitis
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Local burns
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Recent failed intraosseous attempt
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Prior surgery
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Compartment syndrome
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Every other local specific situations
4- Pregnancy woman
5- Patient with no national health or universal plan affiliation coverage
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Assistance Publique - Hôpitaux de Paris
Investigators
- Principal Investigator: LAPOSTOLLE Frédéric, PhD MD, APHP
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- P170918J