Intraosseous Catheter Confirmation Study

NACompletedINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

July 23, 2019

Primary Completion Date

May 1, 2022

Study Completion Date

May 1, 2022

Conditions
Critical Illness
Interventions
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.

Trial Locations (1)

07103

University Hospital, Newark

All Listed Sponsors
lead

Rutgers, The State University of New Jersey

OTHER

NCT03908879 - Intraosseous Catheter Confirmation Study | Biotech Hunter | Biotech Hunter