Intraosseous Catheter Confirmation Study

Study Overview
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Brief Summary
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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).

Official Title
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Prospective Diagnostic Accuracy Study Comparing Sensitivity and Specificity of Methods Used to Confirm Correct Placement of an Intraosseous (IO) Catheter

Conditions
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Critical Illness

Intervention / Treatment
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* Procedure: Standard intraosseous (IO) catheter confirmation procedure
* Procedure: Color flow Doppler intraosseous (IO) catheter confirmation procedure
* Procedure: Pressure transduction intraosseous (IO) catheter confirmation procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Age less than 18 years old Pregnant patients Prisoner/incarcerated Patients unable to undergo all three intraosseous placement confirmatory methods

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: All study participants will undergo all confirmation tests
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intraosseous (IO) catheter placement confirmation methods<br>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. | Procedure: Standard intraosseous (IO) catheter confirmation procedure<br>* 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.<br>* Other names: Method 1;Procedure: Color flow Doppler intraosseous (IO) catheter confirmation procedure<br>* 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.<br>* Other names: Method 2;Procedure: Pressure transduction intraosseous (IO) catheter confirmation procedure<br>* 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.<br>* Other names: Method 3;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | Within 1 week of ultrasound images and pressure transduction images being created by the physician placing the IO catheter | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IO catheter pressure | Pressures measured from transducing the IO catheter: systolic pressure, diastolic pressure, mean pressure | 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 | Within 24 hours of intraosseous (IO) catheter insertion | 
| Number of attempts to place IO catheter | Number of attempts made to place an IO catheter | Within 24 hours of intraosseous (IO) catheter insertion | 
| Complications related to IO catheter | Complications associated with the IO catheter after insertion | Within 28 days of IO catheter insertion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intraosseous catheter, Intraosseous access, Resuscitation, Diagnostic accuracy