Intra-Osseous Access in Difficult Vascular Access Cases
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 3
- Locations
- 2
- Primary Endpoint
- 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.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
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.
Time Frame: • 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 Outcomes
- To evaluate morbidity depending on the strategy used.(Hours 72)
- To determine the length of stay in hospital(Days 28)
- To evaluate mortality depending on the strategy used.(Days 28)
- 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)
- 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)
- 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)