Clinical trial NCT03908879: Intraosseous Catheter Confirmation Study
Official title: Prospective Diagnostic Accuracy Study Comparing Sensitivity and Specificity of Methods Used to Confirm Correct Placement of an Intraosseous (IO) Catheter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Keywords: Intraosseous catheter
Intraosseous access
Resuscitation
Diagnostic accuracy
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2019-04-09
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All study participants will undergo all confirmation tests
Primary purpose: DIAGNOSTIC

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).


Eligibility criteria: 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

Primary outcomes:
measure: Categorical determination of correct IO catheter placement by physicians placing the catheter
timeFrame: Within 24 hours of intraosseous (IO) catheter insertion
measure: Categorical determination of correct IO catheter placement by blinded reviewers
timeFrame: Within 1 week of ultrasound images and pressure transduction images being created by the physician placing the IO catheter
Secondary outcomes:
measure: IO catheter pressure
timeFrame: Within 24 hours of intraosseous (IO) catheter insertion
measure: Systemic blood pressure
timeFrame: Within 24 hours of intraosseous (IO) catheter insertion
measure: Number of attempts to place IO catheter
timeFrame: Within 24 hours of intraosseous (IO) catheter insertion
measure: Complications related to IO catheter
timeFrame: Within 28 days of IO catheter insertion
Other outcomes:
Locations:
city: Newark
country: United States
facility: University Hospital
state: New Jersey
Study officials:
affiliation: Rutgers, The State University of New Jersey
name: Yonatan Greenstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Tsung 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.
citation: Frascone 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.
citation: Salzman 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.