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Not Yet Recruiting NCT05708833

Intra-Osseous Access in Difficult Vascular Access Cases

Conditions: Hemodynamic Instability

Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 1180
Sponsor: Assistance Publique - Hôpitaux de Paris

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: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) ANDPatient with hemodynamic failure defined as:systolic blood pressure (SBP) < 90 mm Hg (2 measures) orcardiac arrest orAny situation requiring intubationExclusion Criteria:1- Age < 18 years2- Venous access already available3- Known contra-indications to intraosseous access (i.e. bilateral lesions):Bone fractureSkin infectionOsteoporosisOsteomyelitisLocal burnsRecent failed intraosseous attemptPrior surgeryCompartment syndromeEvery other local specific situations4- Pregnancy woman5- Patient with no national health or universal plan affiliation coverage

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05708833). StuddyBuddy aggregates publicly available trial information.