Critical Illness
Conditions
Keywords
Intraosseous catheter, Intraosseous access, Resuscitation, Diagnostic accuracy
Brief 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) 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).
Interventions
PROCEDUREStandard intraosseous (IO) catheter confirmation procedure
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.
PROCEDUREColor flow Doppler intraosseous (IO) catheter confirmation procedure
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.
PROCEDUREPressure transduction intraosseous (IO) catheter confirmation procedure
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.
Sponsors
Rutgers, The State University of New Jersey
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
There is only one arm because all participants will be undergoing the same protocol. To evaluate inter-operator variability for methods 2 and 3, co-investigators will be reviewing saved images recorded by the physicians who placed the intraosseous (IO) catheter. Saved images include the color flow Doppler image for method 2 and the pressure waveform for method 3. Two co-investigators will review saved images from method 2, blinded and independently. Two other co-investigators will review saved images from method 3, blinded and independently. If the results of the two co-investigators for method 2 or method 3 is discordant then a third blinded reviewer will review the saved image for the method with discordant results.
Intervention model description
All study participants will undergo all confirmation tests
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Categorical determination of correct IO catheter placement by physicians placing the catheter | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IO catheter pressure | Within 24 hours of intraosseous (IO) catheter insertion | Pressures measured from transducing the IO catheter: systolic pressure, diastolic pressure, mean pressure |
| Systemic blood pressure | Within 24 hours of intraosseous (IO) catheter insertion | Pressures measured from a noninvasive blood pressure cuff or an arterial line: systolic pressure diastolic pressure mean pressure |
| Number of attempts to place IO catheter | Within 24 hours of intraosseous (IO) catheter insertion | Number of attempts made to place an IO catheter |
| Complications related to IO catheter | Within 28 days of IO catheter insertion | Complications associated with the IO catheter after insertion |
Countries
United States
Outcome results
None listed