Intra-Osseous Access in Difficult Vascular Access Cases

NCT05708833 | Terminated

• 1 other identifier: P170918J
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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 with cardiac arrest: Time required for a return of spontaneous circulation (ROSC). Only the first ROSC will be considered.

  • In patients with cardiac arrest: Return of spontaneous circulation (ROSC), an average of 1 hour

• 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 with hemodynamic failure: delay to reach a systolic blood pressure correction, i.e. systolic blood pressure \> 90 mm Hg. Systolic blood pressure will be assessed every 5 minutes after the placement of the intravenous line. Two consecutive measures are required to reach the end-point. In the cases where continuous invasive blood pressure monitoring will be available, systolic blood pressure \> 90 mm Hg \> 1 minute will be required.

  • In patients with hemodynamic failure: Reach a systolic blood pressure correction, an average of 1 hour

• 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: time required to achieve intubation.

  • In patients requiring endo-tracheal intubation: Achieve intubation, an average of 1 hour

Secondary Outcomes (23)

• To characterize the conditions for implementation of the procedure, depending on the strategy used.

  1 minute

• To characterize the conditions for implementation of the procedure, depending on the strategy used.

  In patients with cardiac arrest: Return of spontaneous circulation (ROSC), an average of 1 hour

• To characterize the conditions for implementation of the procedure, depending on the strategy used.

  In patients with hemodynamic failure: Reach a systolic blood pressure correction, an average of 1 hour

• 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

• To characterize the conditions for implementation of the procedure, depending on the strategy used.

  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

Study Arms (2)

intraosseous venous access

EXPERIMENTAL

intraosseous venous access

Device: Intraosseous venous access

peripheral venous access

ACTIVE COMPARATOR

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

Device: Peripheral venous access

Interventions

Intraosseous venous access DEVICE

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

intraosseous venous access

Peripheral venous access 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)

peripheral venous access

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Age \< 18 years
• Venous access already available
• 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
• Pregnancy woman
• Patient with no national health or universal plan affiliation coverage

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Avicenne

Bobigny, France, 93000, France

Location

Study Officials

• LAPOSTOLLE Frédéric, PhD MD

  APHP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Interventional study with randomisation (1:1)

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: February 1, 2023
• Study Start: March 2, 2023
• Primary Completion: April 24, 2024
• Study Completion: September 10, 2024
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)