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Intraosseous Catheter Confirmation Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03908879
Recruitment Status : Completed
First Posted : April 9, 2019
Last Update Posted : October 25, 2022
Sponsor:
Information provided by (Responsible Party):
Yonatan Greenstein, MD, Rutgers, The State University of New Jersey

Study Description
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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).

Condition or disease Intervention/treatment Phase
Critical Illness Procedure: Standard intraosseous (IO) catheter confirmation procedure Procedure: Color flow Doppler intraosseous (IO) catheter confirmation procedure Procedure: Pressure transduction intraosseous (IO) catheter confirmation procedure Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: All study participants will undergo all confirmation tests
Masking: None (Open Label)
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.
Primary Purpose: Diagnostic
Official Title: Prospective Diagnostic Accuracy Study Comparing Sensitivity and Specificity of Methods Used to Confirm Correct Placement of an Intraosseous (IO) Catheter
Actual Study Start Date : July 23, 2019
Actual Primary Completion Date : May 1, 2022
Actual Study Completion Date : May 1, 2022
Arms and Interventions
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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 Name: 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 Name: 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 Name: Method 3


Outcome Measures
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Primary Outcome Measures :
  1. Categorical determination of correct IO catheter placement by physicians placing the catheter [ Time Frame: 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

  2. Categorical determination of correct IO catheter placement by blinded reviewers [ Time Frame: 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 Outcome Measures :
  1. IO catheter pressure [ Time Frame: Within 24 hours of intraosseous (IO) catheter insertion ]
    Pressures measured from transducing the IO catheter: systolic pressure, diastolic pressure, mean pressure

  2. Systemic blood pressure [ Time Frame: 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

  3. Number of attempts to place IO catheter [ Time Frame: Within 24 hours of intraosseous (IO) catheter insertion ]
    Number of attempts made to place an IO catheter

  4. Complications related to IO catheter [ Time Frame: Within 28 days of IO catheter insertion ]
    Complications associated with the IO catheter after insertion


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03908879


Locations
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United States, New Jersey
University Hospital
Newark, New Jersey, United States, 07103
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Investigators
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Principal Investigator: Yonatan Greenstein, MD Rutgers, The State University of New Jersey
More Information
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Publications:

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Responsible Party: Yonatan Greenstein, MD, Associate Professor of Medicine, Division of Pulmonary & Critical Care Medicine, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT03908879    
Other Study ID Numbers: Pro2019000600
First Posted: April 9, 2019    Key Record Dates
Last Update Posted: October 25, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yonatan Greenstein, MD, Rutgers, The State University of New Jersey:
Intraosseous catheter
Intraosseous access
Resuscitation
Diagnostic accuracy
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes