An interventional study of NIO in Intraosseous Access and Resuscitation, sponsored by Medical University of Warsaw. Completed at 1 site in Poland. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-03-17.
Sponsored by Medical University of Warsaw · Not applicable, Interventional, and Treatment
The investigators sought to compare the intraosseous access success rates of the proximal tibia and the proximal humerus using new Intraosseous access device "NIO" in an adult cadaver model during simulated resuscitation.
Medical University of Warsaw is the lead sponsor of 316 studies on the registry; 87 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Assumption of intraosseous access into the proximal tibia. Simulation of continous resuscitation was carried out using a system of chest compression LifeLine ARM.
Device: NIO
Assumption of intraosseous access into the proximal humerus. Simulation of continous resuscitation was carried out using a system of chest compression LifeLine ARM.
Device: NIO
Intraosseous access device NIO (Defibtech)
Success rate
Success rate of IO cannulation was defined as successful administration of infusion solutions via the performed IO access. Failure was defined as extravasation or unsuccessful (first) effort of IO insertion.
Time frame: 1 day
Time of IO insertion
Procedure time was defined as the duration of picking up the prepared set of IO device from the shelf, preparation of the access set and patients' insertion site including disinfection and draping, insertion procedure of the cannula itself, assembling of the access set and first successful administration of drugs or infusion solutions through the newly established vascular access. The time taken for each infusion attempt was measured offline while reviewing procedures by videotape, and subsequently entered into a computer spreadsheet. Times were measured in seconds.
Time frame: 1 day
Ease-of-use
ease-of-use of the NIO in tibia and humerus using a five-point Likert Scale ("the device is easy to use"; 1-strongly disagree, 2-disagree, 3-neither agree nor disagree, 4-agree, 5-strongly agree).
Time frame: 1 day
first location
Participants were asked to record their "first location access" tibia or humerus
Time frame: 1 day
Plan to share: Undecided
This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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Cadaver
Medical University of Warsaw