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Intra-Osseous Access in Difficult Vascular Access Cases

Not Applicable
Recruiting
Conditions
Hemodynamic Instability
Interventions
Device: Intraosseous venous access
Device: Peripheral venous access
Registration Number
NCT05708833
Lead 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
1180
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

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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

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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
intraosseous venous accessIntraosseous venous accessintraosseous venous access
peripheral venous accessPeripheral venous accessLimiting use of intraosseous access (intraosseous access possible after 3 attempts of peripheral venous access)
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
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 evaluate morbidity depending on the strategy used.Hours 72

Need to replace the venous access

To determine the length of stay in hospitalDays 28

Length of stay in hospital

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).

Trial Locations

Locations (1)

Hôpital Avicenne

🇫🇷

Bobigny, France

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