Intra-Osseous Access in Difficult Vascular Access Cases

Hemodynamic Instability Clinical Trial

— IODA  

Official title:

Intra-Osseous Access in Difficult Vascular Access Cases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05708833
• Other study ID #: P170918J
• Status: Recruiting
• Phase: N/A
• Start date: March 2, 2023
• Est. completion date: November 2, 2024

Study information

• Verified date: June 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: LAPOSTOLLE Frédéric, PhD MD
• Phone: +33 1 48 96 44 54
• Email: frederic.lapostolle[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1180
• Est. completion date: November 2, 2024
• Est. primary completion date: July 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemodynamic Instability

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Avicenne	Bobigny

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	To characterize the conditions for implementation of the procedure, depending on the strategy used.	Failure to place the catheter defined by the absence of infusion or by withdrawal of the catheter within one minute after the opening of the infusion	1 minute
Secondary	To characterize the conditions for implementation of the procedure, depending on the strategy used.	Number of punctures	In patients with cardiac arrest: Return of spontaneous circulation (ROSC), an average of 1 hour
Secondary	To characterize the conditions for implementation of the procedure, depending on the strategy used.	Number of punctures	In patients with hemodynamic failure: Reach a systolic blood pressure correction, an average of 1 hour
Secondary	To characterize the conditions for implementation of the procedure, depending on the strategy used.	Number of sites treated	In patients requiring endo-tracheal intubation: Achieve intubation, an average of 1 hour
Secondary	To characterize the conditions for implementation of the procedure, depending on the strategy used.	Use of alternative routes (central venous access, oral, rectal, subcutaneous, intramuscular - and intra-osseous in the control group)	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
Secondary	To characterize the conditions for implementation of the procedure, depending on the strategy used.	Use of alternative routes (central venous access, oral, rectal, subcutaneous, intramuscular - and intra-osseous in the control group)	In patients with cardiac arrest: Return of spontaneous circulation (ROSC), an average of 1 hour
Secondary	To characterize the conditions for implementation of the procedure, depending on the strategy used.	Use of alternative routes (central venous access, oral, rectal, subcutaneous, intramuscular - and intra-osseous in the control group)	In patients with hemodynamic failure: Reach a systolic blood pressure correction, an average of 1 hour
Secondary	To characterize the conditions for implementation of the procedure, depending on the strategy used.	Use of assistance tools (ultrasound, infra-red)	In patients requiring endo-tracheal intubation: Achieve intubation, an average of 1 hour
Secondary	To characterize the conditions for implementation of the procedure, depending on the strategy used.	Delays in placing venous access	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
Secondary	To characterize the conditions for implementation of the procedure, depending on the strategy used.	Delays in placing venous access	In patients with cardiac arrest: Return of spontaneous circulation (ROSC), an average of 1 hour
Secondary	To characterize the conditions for implementation of the procedure, depending on the strategy used.	Delays in placing venous access	In patients with hemodynamic failure: Reach a systolic blood pressure correction, an average of 1 hour
Secondary	To characterize the conditions for implementation of the procedure, depending on the strategy used.	Delays for administration of drugs/solutes	In patients with cardiac arrest: Return of spontaneous circulation (ROSC), an average of 1 hour
Secondary	To characterize the conditions for implementation of the procedure, depending on the strategy used.	Delays for administration of drugs/solutes	In patients with hemodynamic failure: Reach a systolic blood pressure correction, an average of 1 hour
Secondary	To characterize the conditions for implementation of the procedure, depending on the strategy used.	Delays for administration of drugs/solutes	In patients requiring endo-tracheal intubation: Achieve intubation, an average of 1 hour
Secondary	To determine the length of stay in hospital	Length of stay in hospital	Days 28
Secondary	To evaluate morbidity depending on the strategy used.	Non-functional venous	In patients with cardiac arrest: Return of spontaneous circulation (ROSC), an average of 1 hour
Secondary	To evaluate morbidity depending on the strategy used.	Non-functional venous	In patients with hemodynamic failure: Reach a systolic blood pressure correction, an average of 1 hour
Secondary	To evaluate morbidity depending on the strategy used.	Non-functional venous	IIn patients requiring endo-tracheal intubation: Achieve intubation, In patients with hemodynamic failure: Reach a systolic blood pressure correction, an average of 1 hour
Secondary	To evaluate morbidity depending on the strategy used.	Local complication (subcutaneous diffusion, hematoma, pain...)	Days 28
Secondary	To evaluate morbidity depending on the strategy used.	Need to replace the venous access	Hours 72
Secondary	To evaluate mortality depending on the strategy used.	Death	Days 28
Secondary	To evaluate the patient's feedback, depending on the strategy used.	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.	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
Secondary	To evaluate the team's feedback, depending on the strategy used.	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).	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