Intra-Osseous Access in Difficult Vascular Access Cases

NCT ID: NCT05708833

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-02
• Study Completion Date: 2024-09-10

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.

Conditions

Hemodynamic Instability

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

intraosseous venous access

intraosseous venous access

Group Type: EXPERIMENTAL

Intraosseous venous access

Intervention Type: DEVICE

Immediate placement of humeral intra-osseous venous access (after a first failed attempt of peripheral venous access)

peripheral venous access

Limiting use of intraosseous access (intraosseous access possible after 3 attempts of peripheral venous access)

Group Type: ACTIVE_COMPARATOR

Peripheral venous access

Intervention Type: DEVICE

Looking for peripheral venous access, changing the site of puncture, the caliber of the catheter and/or the operator and/or assistance tools (ultrasound, infra-red guidance...) and/or using another route (oral, rectal, subcutaneous, intramuscular route and central venous access)

Interventions

Intraosseous venous access

Immediate placement of humeral intra-osseous venous access (after a first failed attempt of peripheral venous access)

Intervention Type: DEVICE

Peripheral venous access

Looking for peripheral venous access, changing the site of puncture, the caliber of the catheter and/or the operator and/or assistance tools (ultrasound, infra-red guidance...) and/or using another route (oral, rectal, subcutaneous, intramuscular route and central venous access)

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

LAPOSTOLLE Frédéric, PhD MD

Role: PRINCIPAL_INVESTIGATOR

APHP

Locations

Hôpital Avicenne

Bobigny, France, France

Countries

France

Other Identifiers

P170918J

Identifier Type: -

Identifier Source: org_study_id