Intraosseous Catheter Confirmation Study

Rutgers The State University of New Jersey

Status: Completed

Conditions: Critical Illness

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03908879

Pro2019000600

Details and patient eligibility

About

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).

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

Intraosseous (IO) catheter placement confirmation methods

Experimental group

Description:

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.

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