Intraosseous Catheter Confirmation Study

NCT03908879 | Completed DMC

• 1 other identifier: Pro2019000600
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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).

Conditions

Critical Illness

Keywords

Intraosseous catheter; Intraosseous access; Resuscitation; Diagnostic accuracy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• IO catheter pressure

  Within 24 hours of intraosseous (IO) catheter insertion

• Systemic blood pressure

  Within 24 hours of intraosseous (IO) catheter insertion

• Number of attempts to place IO catheter

  Within 24 hours of intraosseous (IO) catheter insertion

• Complications related to IO catheter

  Within 28 days of IO catheter insertion

Study Arms (1)

Intraosseous (IO) catheter placement confirmation methods

EXPERIMENTAL

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; Procedure: Color flow Doppler intraosseous (IO) catheter confirmation procedure; Procedure: Pressure transduction intraosseous (IO) catheter confirmation procedure

Interventions

Standard intraosseous (IO) catheter confirmation procedure 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.

Also known as: Method 1

Intraosseous (IO) catheter placement confirmation methods

Color flow Doppler intraosseous (IO) catheter confirmation procedure 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.

Also known as: Method 2

Intraosseous (IO) catheter placement confirmation methods

Pressure transduction intraosseous (IO) catheter confirmation procedure 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.

Also known as: Method 3

Intraosseous (IO) catheter placement confirmation methods

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Age less than 18 years old
• Pregnant patients
• Prisoner/incarcerated
• Patients unable to undergo all three intraosseous placement confirmatory methods

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

University Hospital

Newark, New Jersey, 07103, United States

Location

Related Publications (5)

• 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.

  PMID: 17222940 BACKGROUND

• 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.

  PMID: 19395142 BACKGROUND

• 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.

  PMID: 24440591 BACKGROUND

• 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.

  PMID: 28418753 BACKGROUND

• Greenstein YY, Ferrara S, Jomi J, Soetanto V, Zuckerman O, Sena A, Ostrovsky I, Alerhand S. A Prospective Comparison of Standard Technique, Doppler Ultrasonography, and Pressure Waveform Analysis for Confirming Intraosseous Catheter Placement. J Intensive Care Med. 2024 Mar;39(3):222-229. doi: 10.1177/08850666231199086. Epub 2023 Aug 30.

  PMID: 37647305 DERIVED

MeSH Terms

Conditions

Critical Illness

Interventions

Jupiter

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Planets; Solar System; Astronomical Objects; Astronomical Phenomena; Physical Phenomena

Study Officials

• Yonatan Greenstein, MD

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine, Division of Pulmonary & Critical Care Medicine

Model Details: All study participants will undergo all confirmation tests

Study Record Dates

• First Submitted: April 4, 2019
• First Posted: April 9, 2019
• Study Start: July 23, 2019
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: September 8, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)