Critical IllnessNCT03908879
Intraosseous Catheter Confirmation Study
A study testing Standard intraosseous (IO) catheter confirmation procedure, Color flow Doppler intraosseous (IO) catheter confirmation procedure and Pressure transduction intraosseous (IO) catheter confirmation procedure in people with Critical Illness, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
This is a prospective diagnostic accuracy study investigating the sensitivity and specificity of methods used to confirm correct placement of an intraosseous (IO) catheter. Intraosseous catheters allow medical providers to rapidly administer fluids and medications to critically ill patients when intravenous (IV)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- Standard intraosseous (IO) catheter confirmation procedure, Color flow Doppler intraosseous (IO) catheter confirmation procedure and Pressure transduction intraosseous (IO) catheter confirmation procedure
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2019to 1 May 2022
- 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
- Patients greater than 18 years of age
- Full code
- Require placement of an intraosseous catheter for emergent resuscitation due to lack of reliable intravenous access
- Capable of undergoing all three intraosseous placement confirmatory methods
Who cannot join
- Age less than 18 years old
- Pregnant patients
- Prisoner/incarcerated
- Patients unable to undergo all three intraosseous placement confirmatory methods
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Diagnostic Accuracy Study Comparing Sensitivity and Specificity of Methods Used to Confirm Correct Placement of an Intraosseous (IO) Catheter
This is a prospective diagnostic accuracy study investigating the sensitivity and specificity of methods used to confirm correct placement of an intraosseous (IO) catheter. Intraosseous catheters allow medical providers to rapidly administer fluids and medications to critically ill patients when intravenous (IV) access is not present or difficult to achieve. It is standard of care to confirm the correct placement of an IO catheter prior to using it to administer medications or fluids. Three IO placement confirmatory tests will be performed on all research subjects using a standardized protocol. There will be two index tests (the method utilized by most of the medical community evaluating the stability of the catheter, ability to aspirate blood or bone marrow and ability to administer fluids without visible or palpable extravasation as well as the method of demonstrating color flow Doppler only within the intraosseous space during bedside ultrasound exam) and one reference test (ability to visualized a pulsatile waveform when the IO catheter is attached to a pressure transducer). Primary outcome measures of the study will be the determination of correct or incorrect IO catheter placement from the confirmation methods. This data will be used to investigate the primary endpoints of sensitivity and specificity of the confirmation tests as well as inter-operator variability interpreting the raw data from the confirmation methods. Secondary outcomes include complications from the IO catheter. The goal of this study is to see if a more sensitive and specific method of IO catheter confirmation can reliably be performed by different physicians and reduce the amount of complications associated with the catheters. Additional subgroup analyses will be performed in regards to the research subjects BMI and the anatomic site selected for IO catheter use (proximal tibia or humeral head).
- Conditions
- Critical Illness
- Being tested
- Standard intraosseous (IO) catheter confirmation procedure, Color flow Doppler intraosseous (IO) catheter confirmation procedure, Pressure transduction intraosseous (IO) catheter confirmation procedure
- Keywords
- Intraosseous catheter, Intraosseous access, Resuscitation, Diagnostic accuracy
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard intraosseous (IO) catheter confirmation procedureProcedure or surgery
Also called Method 1
The physician will evaluate the ability or inability of the intraosseous (IO) catheter to stand upright unassisted, the ability or inability to aspirate blood or bone marrow from the IO catheter, and whether or not there is visible or palpable extravasation of infusate from the IO catheter insertion site or surrounding subcutaneous tissue during IO catheter use.
Color flow Doppler intraosseous (IO) catheter confirmation procedureProcedure or surgery
Also called Method 2
The high frequency probe of a portable ultrasound with color flow Doppler is placed adjacent to the intraosseous (IO) catheter, visualizing the IO space in long or short axis. Color flow Doppler signal will be turned on during IO use and the physician will determine if the Doppler signal is in the intraosseous space or the extraosseous space. Saved data of the ultrasound image will be reviewed independently by at least two blinded reviewers. If the conclusions from the blinded reviewers are discordant then a third blinded reviewer will evaluate the saved data.
Pressure transduction intraosseous (IO) catheter confirmation procedureProcedure or surgery
Also called Method 3
The intraosseous (IO) catheter will be attached to a pressure transducer to demonstrate a waveform on the telemetry monitor. Physicians will evaluate for the presence of a pulsatile waveform with objective measurements of a systolic pressure, diastolic pressure and mean pressure. Saved data of the waveform image will be reviewed independently by at least two blinded reviewers. If the conclusions from the blinded reviewers are discordant then a third blinded reviewer will evaluate the saved data.
| Study group | Role | What they receive |
|---|---|---|
| Intraosseous (IO) catheter placement confirmation methods | Experimental | All patients will undergo all three confirmation methods/procedures. Method 1 is a triage test and an index test. Method 2 is an index test. Method 3 is a reference standard. None of the procedures being performed in this study are regulated by the United States Food and Drug Administration. Receives: Procedure: Standard intraosseous (IO) catheter confirmation procedure; Procedure: Color flow Doppler intraosseous (IO) catheter confirmation procedure; Procedure: Pressure transduction intraosseous (IO) catheter confirmation procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Categorical determination of correct IO catheter placement by physicians placing the catheter
Categorical determination (yes/no) regarding correct IO catheter placement in the intraosseous space of all three confirmatory methods from the physicians placing the IO catheter
Measured: Within 24 hours of intraosseous (IO) catheter insertion
Categorical determination of correct IO catheter placement by blinded reviewers
Categorical determination (yes/no) regarding correct IO catheter placement in the intraosseous space for method 2 and method 3 by the blinded reviewers
Measured: Within 1 week of ultrasound images and pressure transduction images being created by the physician placing the IO catheter
Secondary outcomes (4)
IO catheter pressure
Pressures measured from transducing the IO catheter: systolic pressure, diastolic pressure, mean pressure
Measured: Within 24 hours of intraosseous (IO) catheter insertion
Systemic blood pressure
Pressures measured from a noninvasive blood pressure cuff or an arterial line: systolic pressure diastolic pressure mean pressure
Measured: Within 24 hours of intraosseous (IO) catheter insertion
Number of attempts to place IO catheter
Number of attempts made to place an IO catheter
Measured: Within 24 hours of intraosseous (IO) catheter insertion
Complications related to IO catheter
Complications associated with the IO catheter after insertion
Measured: Within 28 days of IO catheter insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start23 Jul 2019
- Primary completion1 May 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All study participants will undergo all confirmation tests
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yonatan Greenstein, MD, Rutgers, The State University of New Jersey
- Investigators
- Yonatan Greenstein, MD, Principal investigator, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03908879
- Sponsor's protocol ID
- Pro2019000600
- Status last verified
- Sep 2023
- First submitted
- 4 Apr 2019
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stone MB, Teismann NA, Wang R. Ultrasonographic confirmation of intraosseous needle placement in an adult unembalmed cadaver model. Ann Emerg Med. 2007 Apr;49(4):515-9. doi: 10.1016/j.annemergmed.2006.11.009. Epub 2007 Jan 12.
PubMed 17222940Tsung JW, Blaivas M, Stone MB. Feasibility of point-of-care colour Doppler ultrasound confirmation of intraosseous needle placement during resuscitation. Resuscitation. 2009 Jun;80(6):665-8. doi: 10.1016/j.resuscitation.2009.03.009. Epub 2009 Apr 22.
PubMed 19395142Frascone RJ, Salzman JG, Ernest EV, Burnett AM. Use of an intraosseous device for invasive pressure monitoring in the ED. Am J Emerg Med. 2014 Jun;32(6):692.e3-4. doi: 10.1016/j.ajem.2013.12.029. Epub 2013 Dec 18.
PubMed 24440591Salzman JG, Loken NM, Wewerka SS, Burnett AM, Zagar AE, Griffith KR, Bliss PL, Peterson BK, Ward CJ, Frascone RJ. Intraosseous Pressure Monitoring in Healthy Volunteers. Prehosp Emerg Care. 2017 Sep-Oct;21(5):567-574. doi: 10.1080/10903127.2017.1302529. Epub 2017 Apr 18.
PubMed 28418753Greenstein YY, Ferrara S, Jomi J, Soetanto V, Zuckerman O, Sena A, Ostrovsky I, Alerhand S. A Prospective Comparison of Standard Technique, Doppler Ultrasonography, and Pressure Waveform Analysis for Confirming Intraosseous Catheter Placement. J Intensive Care Med. 2024 Mar;39(3):222-229. doi: 10.1177/08850666231199086. Epub 2023 Aug 30.
PubMed 37647305
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Diagnostic Accuracy Study Comparing Sensitivity and Specificity of Methods Used to Confirm Correct Placement of an Intraosseous (IO) Catheter
- ClinicalTrials.gov ID
- NCT03908879
- Acronym / sponsor ID
- Pro2019000600
- Conditions
- Critical Illness
- Keywords
- Intraosseous catheter, Intraosseous access, Resuscitation, Diagnostic accuracy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 23 Jul 2019 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 9 Apr 2019 (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.
This is a prospective diagnostic accuracy study investigating the sensitivity and specificity of methods used to confirm correct placement of an intraosseous (IO) catheter. Intraosseous catheters allow medical providers to rapidly administer fluids and medications to critically ill patients when intravenous (IV) access is not present or difficult to achieve. It is standard of care to confirm the correct placement of an IO catheter prior to using it to administer medications or fluids. Three IO placement confirmatory tests will be performed on all research subjects using a standardized protocol. There will be two index tests (the method utilized by most of the medical community evaluating the stability of the catheter, ability to aspirate blood or bone marrow and ability to administer fluids without visible or palpable extravasation as well as the method of demonstrating color flow Doppler only within the intraosseous space during bedside ultrasound exam) and one reference test (ability to visualized a pulsatile waveform when the IO catheter is attached to a pressure transducer). Primary outcome measures of the study will be the determination of correct or incorrect IO catheter placement from the confirmation methods. This data will be used to investigate the primary endpoints of sensitivity and specificity of the confirmation tests as well as inter-operator variability interpreting the raw data from the confirmation methods. Secondary outcomes include complications from the IO catheter. The goal of this study is to see if a more sensitive and specific method of IO catheter confirmation can reliably be performed by different physicians and reduce the amount of complications associated with the catheters. Additional subgroup analyses will be performed in regards to the research subjects BMI and the anatomic site selected for IO catheter use (proximal tibia or humeral head).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All study participants will undergo all confirmation tests
| Arm | Type | Receives |
|---|---|---|
| Intraosseous (IO) catheter placement confirmation methods | Experimental | Procedure: Standard intraosseous (IO) catheter confirmation procedure, Procedure: Color flow Doppler intraosseous (IO) catheter confirmation procedure, Procedure: Pressure transduction intraosseous (IO) catheter confirmation procedureAll patients will undergo all three confirmation methods/procedures. Method 1 is a triage test and an index test. Method 2 is an index test. Method 3 is a reference standard. None of the procedures being performed in this study are regulated by the United States Food and Drug Administration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients greater than 18 years of age
- Full code
- Require placement of an intraosseous catheter for emergent resuscitation due to lack of reliable intravenous access
- Capable of undergoing all three intraosseous placement confirmatory methods
Key exclusion criteria (4 listed)
- Age less than 18 years old
- Pregnant patients
- Prisoner/incarcerated
- Patients unable to undergo all three intraosseous placement confirmatory methods
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 |
|---|---|---|
| Standard intraosseous (IO) catheter confirmation procedureAlso: Method 1The physician will evaluate the ability or inability of the intraosseous (IO) catheter to stand upright unassisted, the ability or inability to aspirate blood or bone marrow from the IO catheter, and whether or not there is visible or palpable extravasation of infusate from the IO catheter insertion site or surrounding subcutaneous tissue during IO catheter use. | Procedure or surgery | Intraosseous (IO) catheter placement confirmation methods |
| Color flow Doppler intraosseous (IO) catheter confirmation procedureAlso: Method 2The high frequency probe of a portable ultrasound with color flow Doppler is placed adjacent to the intraosseous (IO) catheter, visualizing the IO space in long or short axis. Color flow Doppler signal will be turned on during IO use and the physician will determine if the Doppler signal is in the intraosseous space or the extraosseous space. Saved data of the ultrasound image will be reviewed independently by at least two blinded reviewers. If the conclusions from the blinded reviewers are discordant then a third blinded reviewer will evaluate the saved data. | Procedure or surgery | Intraosseous (IO) catheter placement confirmation methods |
| Pressure transduction intraosseous (IO) catheter confirmation procedureAlso: Method 3The intraosseous (IO) catheter will be attached to a pressure transducer to demonstrate a waveform on the telemetry monitor. Physicians will evaluate for the presence of a pulsatile waveform with objective measurements of a systolic pressure, diastolic pressure and mean pressure. Saved data of the waveform image will be reviewed independently by at least two blinded reviewers. If the conclusions from the blinded reviewers are discordant then a third blinded reviewer will evaluate the saved data. | Procedure or surgery | Intraosseous (IO) catheter placement confirmation methods |
Primary outcome
Categorical determination of correct IO catheter placement by physicians placing the catheter
Time frame: Within 24 hours of intraosseous (IO) catheter insertion
Categorical determination (yes/no) regarding correct IO catheter placement in the intraosseous space of all three confirmatory methods from the physicians placing the IO catheter
Categorical determination of correct IO catheter placement by blinded reviewers
Time frame: Within 1 week of ultrasound images and pressure transduction images being created by the physician placing the IO catheter
Categorical determination (yes/no) regarding correct IO catheter placement in the intraosseous space for method 2 and method 3 by the blinded reviewers
4 secondary outcomes
IO catheter pressure
Time frame: Within 24 hours of intraosseous (IO) catheter insertion
Systemic blood pressure
Time frame: Within 24 hours of intraosseous (IO) catheter insertion
Number of attempts to place IO catheter
Time frame: Within 24 hours of intraosseous (IO) catheter insertion
Complications related to IO catheter
Time frame: Within 28 days of IO catheter insertion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- Background: PubMed 17222940Stone MB, Teismann NA, Wang R. Ultrasonographic confirmation of intraosseous needle placement in an adult unembalmed cadaver model. Ann Emerg Med. 2007 Apr;49(4):515-9. doi: 10.1016/j.annemergmed.2006.11.009. Epub 2007 Jan 12.
- Background: PubMed 19395142Tsung JW, Blaivas M, Stone MB. Feasibility of point-of-care colour Doppler ultrasound confirmation of intraosseous needle placement during resuscitation. Resuscitation. 2009 Jun;80(6):665-8. doi: 10.1016/j.resuscitation.2009.03.009. Epub 2009 Apr 22.
- Background: PubMed 24440591Frascone RJ, Salzman JG, Ernest EV, Burnett AM. Use of an intraosseous device for invasive pressure monitoring in the ED. Am J Emerg Med. 2014 Jun;32(6):692.e3-4. doi: 10.1016/j.ajem.2013.12.029. Epub 2013 Dec 18.
- Background: PubMed 28418753Salzman JG, Loken NM, Wewerka SS, Burnett AM, Zagar AE, Griffith KR, Bliss PL, Peterson BK, Ward CJ, Frascone RJ. Intraosseous Pressure Monitoring in Healthy Volunteers. Prehosp Emerg Care. 2017 Sep-Oct;21(5):567-574. doi: 10.1080/10903127.2017.1302529. Epub 2017 Apr 18.
- Derived from this study: PubMed 37647305Greenstein YY, Ferrara S, Jomi J, Soetanto V, Zuckerman O, Sena A, Ostrovsky I, Alerhand S. A Prospective Comparison of Standard Technique, Doppler Ultrasonography, and Pressure Waveform Analysis for Confirming Intraosseous Catheter Placement. J Intensive Care Med. 2024 Mar;39(3):222-229. doi: 10.1177/08850666231199086. Epub 2023 Aug 30.
- Individual participant dataSharing planned: No
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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.
Yonatan Greenstein, MD principal investigator
Rutgers, The State University of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard intraosseous (IO) catheter confirmation procedure, Color flow Doppler intraosseous (IO) catheter confirmation procedure and Pressure transduction intraosseous (IO) catheter confirmation procedure in people with Critical Illness, run by Rutgers, The State University of New Jersey at 1 site in United States.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 8 Sep 2023. 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 United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Categorical determination of correct IO catheter placement by physicians placing the catheter (time frame: Within 24 hours of intraosseous (IO) catheter insertion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03908879, which also lists 5 linked publications.
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 8 Sep 2023.