Hemodynamic InstabilityIODANCT05708833
Intra-Osseous Access in Difficult Vascular Access Cases
A study testing Intraosseous venous access and Peripheral venous access in people with Hemodynamic Instability, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodynamic Instability
- What is being tested?
- Intraosseous venous access and Peripheral venous access
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteFrance
- Study dates
- 2 Mar 2023to 10 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Intraosseous venous access, Peripheral venous access
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraosseous venous accessDevice
Immediate placement of humeral intra-osseous venous access (after a first failed attempt of peripheral venous access)
Peripheral venous accessDevice
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)
| Study group | Role | What they receive |
|---|---|---|
| intraosseous venous access | Experimental | intraosseous venous access Receives: Device: Intraosseous venous access |
| peripheral venous access | Active comparator | Limiting use of intraosseous access (intraosseous access possible after 3 attempts of peripheral venous access) Receives: Device: Peripheral venous access |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: • 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.
Measured: • 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.
Measured: • 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.
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
Measured: 1 minute
To characterize the conditions for implementation of the procedure, depending on the strategy used.
Number of punctures
Measured: 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.
Number of punctures
Measured: 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.
Number of sites treated
Measured: 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.
Use of alternative routes (central venous access, oral, rectal, subcutaneous, intramuscular - and intra-osseous in the control group)
Measured: 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
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)
Measured: 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.
Use of alternative routes (central venous access, oral, rectal, subcutaneous, intramuscular - and intra-osseous in the control group)
Measured: 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.
Use of assistance tools (ultrasound, infra-red)
Measured: 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.
Delays in placing venous access
Measured: 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
To characterize the conditions for implementation of the procedure, depending on the strategy used.
Delays in placing venous access
Measured: 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.
Delays in placing venous access
Measured: 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.
Delays for administration of drugs/solutes
Measured: 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.
Delays for administration of drugs/solutes
Measured: 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.
Delays for administration of drugs/solutes
Measured: In patients requiring endo-tracheal intubation: Achieve intubation, an average of 1 hour
To determine the length of stay in hospital
Length of stay in hospital
Measured: Days 28
To evaluate morbidity depending on the strategy used.
Non-functional venous
Measured: In patients with cardiac arrest: Return of spontaneous circulation (ROSC), an average of 1 hour
To evaluate morbidity depending on the strategy used.
Non-functional venous
Measured: In patients with hemodynamic failure: Reach a systolic blood pressure correction, an average of 1 hour
To evaluate morbidity depending on the strategy used.
Non-functional venous
Measured: IIn patients requiring endo-tracheal intubation: Achieve intubation, In patients with hemodynamic failure: Reach a systolic blood pressure correction, an average of 1 hour
To evaluate morbidity depending on the strategy used.
Local complication (subcutaneous diffusion, hematoma, pain...)
Measured: Days 28
To evaluate morbidity depending on the strategy used.
Need to replace the venous access
Measured: Hours 72
To evaluate mortality depending on the strategy used.
Death
Measured: Days 28
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.
Measured: 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
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).
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start2 Mar 2023
- Primary completion24 Apr 2024
- Study completion10 Sep 2024
Why it stopped: Lack of inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic InstabilityStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional study with randomisation (1:1)
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LAPOSTOLLE Frédéric, PhD MD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05708833
- Sponsor's protocol ID
- P170918J
- Acronym
- IODA
- Status last verified
- Mar 2025
- First submitted
- 6 Apr 2022
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-Osseous Access in Difficult Vascular Access Cases
- ClinicalTrials.gov ID
- NCT05708833
- Acronym / sponsor ID
- IODA / P170918J
- Conditions
- Hemodynamic Instability
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of inclusion
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 2 Mar 2023 (actual)
- Primary completion
- 24 Apr 2024 (actual)
- Study completion
- 10 Sep 2024 (actual)
- First posted
- 1 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Interventional study with randomisation (1:1)
| Arm | Type | Receives |
|---|---|---|
| intraosseous venous access | Experimental | Device: Intraosseous venous accessintraosseous venous access |
| peripheral venous access | Active comparator | Device: Peripheral venous accessLimiting use of intraosseous access (intraosseous access possible after 3 attempts of peripheral venous access) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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:
- Any situation requiring intubation
Key exclusion criteria (14 listed)
- 1- Age < 18 years
- 2- Venous access already available
- Bone fracture
- Skin infection
- Osteoporosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraosseous venous accessImmediate placement of humeral intra-osseous venous access (after a first failed attempt of peripheral venous access) | Device | intraosseous venous access |
| Peripheral venous accessLooking 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) | Device | peripheral venous access |
Primary outcome
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.
Time frame: • In patients with cardiac arrest: Return of spontaneous circulation (ROSC), an average of 1 hour
• In patients with cardiac arrest: Time required for a return of spontaneous circulation (ROSC). Only the first ROSC will be considered.
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.
Time frame: • In patients with hemodynamic failure: Reach a systolic blood pressure correction, an average of 1 hour
• 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.
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.
Time frame: • In patients requiring endo-tracheal intubation: Achieve intubation, an average of 1 hour
• In patients requiring endo-tracheal intubation: time required to achieve intubation.
23 secondary outcomes
To characterize the conditions for implementation of the procedure, depending on the strategy used.
Time frame: 1 minute
To characterize the conditions for implementation of the procedure, depending on the strategy used.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
To characterize the conditions for implementation of the procedure, depending on the strategy used.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
To characterize the conditions for implementation of the procedure, depending on the strategy used.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: In patients requiring endo-tracheal intubation: Achieve intubation, an average of 1 hour
To determine the length of stay in hospital
Time frame: Days 28
To evaluate morbidity depending on the strategy used.
Time frame: In patients with cardiac arrest: Return of spontaneous circulation (ROSC), an average of 1 hour
To evaluate morbidity depending on the strategy used.
Time frame: In patients with hemodynamic failure: Reach a systolic blood pressure correction, an average of 1 hour
To evaluate morbidity depending on the strategy used.
Time frame: IIn patients requiring endo-tracheal intubation: Achieve intubation, In patients with hemodynamic failure: Reach a systolic blood pressure correction, an average of 1 hour
To evaluate morbidity depending on the strategy used.
Time frame: Days 28
To evaluate morbidity depending on the strategy used.
Time frame: Hours 72
To evaluate mortality depending on the strategy used.
Time frame: Days 28
To evaluate the patient's feedback, depending on the strategy used.
Time frame: 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
To evaluate the team's feedback, depending on the strategy used.
Time frame: 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
Results and safety
The study was stopped early (reason given: Lack of inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Hemodynamic Instability
RecruitingPhase 4
Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic Repair
Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm, Abdominal
Not yet recruiting
Dexametedomidine Ketamine Infusion Versus Dexametedomidine Propofol Infusion in Non-compliant Agitated Patients on Continuous Positive Airway Pressure (CPAP) Mask Ventilation in the Intensive Care Unit
CPAP Ventilation, Sedation
RecruitingObservational study
Machine Learning-Assisted Management of Intraoperative Hypotension for Personalized Treatment
Intraoperative Hypotension, Perioperative Care
Not yet recruitingObservational study
Development and Internal Validation of a Multimodal Prediction Score for Early Hemodynamic Deterioration in Adult Polytrauma Patients
Multiple Trauma, Polytrauma
RecruitingObservational study
Internal Jugular Vein Ultrasound and Acute Kidney Injury After Abdominal Surgery
Intraoperative Hypotension, Jugular Veins
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
LAPOSTOLLE Frédéric, PhD MD principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraosseous venous access and Peripheral venous access in people with Hemodynamic Instability, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of inclusion). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: • In patients with cardiac arrest: Return of spontaneous circulation (ROSC), an average of 1 hour). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.