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NCT05708833 | Recruiting | Hemodynamic Instability


Intra-Osseous Access in Difficult Vascular Access Cases
Sponsor:

Assistance Publique - Hôpitaux de Paris

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

Hemodynamic Instability

Intervention/treatment

Intraosseous venous access

Peripheral venous access

Phase

Not Applicable

Study Type : Interventional
Estimated Enrollment : 1180 participants
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Intra-Osseous Access in Difficult Vascular Access Cases
Actual Study Start Date : March 2, 2023
Estimated Primary Completion Date : July 2, 2024
Estimated Study Completion Date : November 2, 2024
Arm Intervention/treatment

Experimental: intraosseous venous access

intraosseous venous access

Device: Intraosseous 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

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
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

Intra-Osseous Access in Difficult Vascular Access Cases

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Intra-Osseous Access in Difficult Vascular Access Cases

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Locations


Recruiting

France,

Hôpital Avicenne

Bobigny, France, 93000

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