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Completed

NCT Number: NCT03908879

Intraosseous Catheter Confirmation Study

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital

Newark, New Jersey, 07103, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Method 1

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.

Other names: Method 2

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.

Other names: Method 3

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Registry information

Official study title

Prospective Diagnostic Accuracy Study Comparing Sensitivity and Specificity of Methods Used to Confirm Correct Placement of an Intraosseous (IO) Catheter

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Apr 9, 2019
Registry last updated
Sep 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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