NCT03908879

Intraosseous Catheter Confirmation Study

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
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.
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.

Timeline

• Start date: 2019-07-23
• Primary completion: 2022-05-01
• Completion: 2022-05-01
• First posted: 2019-04-09
• Last updated: 2023-09-08

Locations

1 site across 1 country: United States