Intraosseous Catheter Confirmation Study
- Conditions
- Critical Illness
- Interventions
- Procedure: Standard intraosseous (IO) catheter confirmation procedureProcedure: Color flow Doppler intraosseous (IO) catheter confirmation procedureProcedure: Pressure transduction intraosseous (IO) catheter confirmation procedure
- Registration Number
- NCT03908879
- Lead Sponsor
- Rutgers, The State University of New Jersey
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
- 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
- Age less than 18 years old
- Pregnant patients
- Prisoner/incarcerated
- Patients unable to undergo all three intraosseous placement confirmatory methods
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intraosseous (IO) catheter placement confirmation methods Pressure transduction intraosseous (IO) catheter confirmation procedure 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. Intraosseous (IO) catheter placement confirmation methods Standard intraosseous (IO) catheter confirmation procedure 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. Intraosseous (IO) catheter placement confirmation methods Color flow Doppler intraosseous (IO) catheter confirmation procedure 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.
- Primary Outcome Measures
Name Time Method 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
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
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
University Hospital
🇺🇸Newark, New Jersey, United States