Clinical trial NCT05708833: Intra-Osseous Access in Difficult Vascular Access Cases
Official title: Intra-Osseous Access in Difficult Vascular Access Cases
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hemodynamic Instability
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-02-01
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Interventional study with randomisation (1:1)
Primary purpose: OTHER

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.


Eligibility criteria: 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

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

Primary outcomes:
measure: 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.
timeFrame: • In patients with cardiac arrest: Return of spontaneous circulation (ROSC), an average of 1 hour
measure: 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.
timeFrame: • In patients with hemodynamic failure: Reach a systolic blood pressure correction, an average of 1 hour
measure: 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.
timeFrame: • In patients requiring endo-tracheal intubation: Achieve intubation, an average of 1 hour
Secondary outcomes:
measure: To characterize the conditions for implementation of the procedure, depending on the strategy used.
timeFrame: 1 minute
measure: To characterize the conditions for implementation of the procedure, depending on the strategy used.
timeFrame: In patients with cardiac arrest: Return of spontaneous circulation (ROSC), an average of 1 hour
measure: To characterize the conditions for implementation of the procedure, depending on the strategy used.
timeFrame: In patients with hemodynamic failure: Reach a systolic blood pressure correction, an average of 1 hour
measure: To characterize the conditions for implementation of the procedure, depending on the strategy used.
timeFrame: In patients requiring endo-tracheal intubation: Achieve intubation, an average of 1 hour
measure: To characterize the conditions for implementation of the procedure, depending on the strategy used.
timeFrame: 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
measure: To characterize the conditions for implementation of the procedure, depending on the strategy used.
timeFrame: In patients with cardiac arrest: Return of spontaneous circulation (ROSC), an average of 1 hour
measure: To characterize the conditions for implementation of the procedure, depending on the strategy used.
timeFrame: In patients with hemodynamic failure: Reach a systolic blood pressure correction, an average of 1 hour
measure: To characterize the conditions for implementation of the procedure, depending on the strategy used.
timeFrame: In patients requiring endo-tracheal intubation: Achieve intubation, an average of 1 hour
measure: To characterize the conditions for implementation of the procedure, depending on the strategy used.
timeFrame: 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
measure: To characterize the conditions for implementation of the procedure, depending on the strategy used.
timeFrame: In patients with cardiac arrest: Return of spontaneous circulation (ROSC), an average of 1 hour
measure: To characterize the conditions for implementation of the procedure, depending on the strategy used.
timeFrame: In patients with hemodynamic failure: Reach a systolic blood pressure correction, an average of 1 hour
measure: To characterize the conditions for implementation of the procedure, depending on the strategy used.
timeFrame: In patients with cardiac arrest: Return of spontaneous circulation (ROSC), an average of 1 hour
measure: To characterize the conditions for implementation of the procedure, depending on the strategy used.
timeFrame: In patients with hemodynamic failure: Reach a systolic blood pressure correction, an average of 1 hour
measure: To characterize the conditions for implementation of the procedure, depending on the strategy used.
timeFrame: In patients requiring endo-tracheal intubation: Achieve intubation, an average of 1 hour
measure: To determine the length of stay in hospital
timeFrame: Days 28
measure: To evaluate morbidity depending on the strategy used.
timeFrame: In patients with cardiac arrest: Return of spontaneous circulation (ROSC), an average of 1 hour
measure: To evaluate morbidity depending on the strategy used.
timeFrame: In patients with hemodynamic failure: Reach a systolic blood pressure correction, an average of 1 hour
measure: To evaluate morbidity depending on the strategy used.
timeFrame: IIn patients requiring endo-tracheal intubation: Achieve intubation, In patients with hemodynamic failure: Reach a systolic blood pressure correction, an average of 1 hour
measure: To evaluate morbidity depending on the strategy used.
timeFrame: Days 28
measure: To evaluate morbidity depending on the strategy used.
timeFrame: Hours 72
measure: To evaluate mortality depending on the strategy used.
timeFrame: Days 28
measure: To evaluate the patient's feedback, depending on the strategy used.
timeFrame: 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
measure: To evaluate the team's feedback, depending on the strategy used.
timeFrame: 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
Other outcomes:
Locations:
city: Bobigny
country: France
facility: Hôpital Avicenne
Study officials:
affiliation: APHP
name: LAPOSTOLLE Frédéric, PhD MD
role: PRINCIPAL_INVESTIGATOR
References: