Intraosseous Catheter Confirmation Study

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).

Study Overview

• Status: Completed
• Conditions: Critical Illness
• Intervention / Treatment: Procedure: Standard intraosseous (IO) catheter confirmation procedure; Procedure: Color flow Doppler intraosseous (IO) catheter confirmation procedure; Procedure: Pressure transduction intraosseous (IO) catheter confirmation procedure

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Newark, New Jersey, United States, 07103
      • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intraosseous (IO) catheter placement confirmation methods; 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; 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.; Other Names: Method 1; Procedure: Color 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.; Other Names: Method 2; Procedure: Pressure 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.; Other Names: Method 3

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Investigators: Principal Investigator: Yonatan Greenstein, MD, Rutgers, The State University of New Jersey

Publications and helpful links

General 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2019
• Primary Completion (Actual): May 1, 2022
• Study Completion (Actual): May 1, 2022

Study Registration Dates

• First Submitted: April 4, 2019
• First Submitted That Met QC Criteria: April 8, 2019
• First Posted (Actual): April 9, 2019

Study Record Updates

• Last Update Posted (Actual): September 8, 2023
• Last Update Submitted That Met QC Criteria: September 6, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Diagnostic accuracy; Resuscitation; Intraosseous catheter; Intraosseous access
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: Pro2019000600

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No