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Clinical Trials/NCT03908879
NCT03908879
Completed
Not Applicable

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

Rutgers, The State University of New Jersey1 site in 1 country34 target enrollmentJuly 23, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Critical Illness
Sponsor
Rutgers, The State University of New Jersey
Enrollment
34
Locations
1
Primary Endpoint
Categorical determination of correct IO catheter placement by blinded reviewers
Status
Completed
Last Updated
2 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
July 23, 2019
End Date
May 1, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yonatan Greenstein, MD

Associate Professor of Medicine, Division of Pulmonary & Critical Care Medicine

Rutgers, The State University of New Jersey

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

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

  • 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 Sites (1)

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