Clinical Trial: Trial Comparing Proximal Tibia and Proximal Humerus Infusion Rates Using the NIO Intraosseous Device

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized Crossover Cadaver Trial Comparing Proximal Tibia and Proximal Humerus Infusion Rates Using the NIO Intraosseous Device During Simulated Cardiopulmonary Resusc

Brief Summary: 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.

Detailed Summary:
Sponsor: Medical University of Warsaw

Current Primary Outcome: Success rate [ Time Frame: 1 day ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Time of IO insertion [ Time Frame: 1 day ]
    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.
  • Ease-of-use [ Time Frame: 1 day ]
    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).
  • first location [ Time Frame: 1 day ]
    Participants were asked to record their "first location access" tibia or humerus


Original Secondary Outcome: Same as current

Information By: Medical University of Warsaw

Dates:
Date Received: February 15, 2016
Date Started: February 2016
Date Completion:
Last Updated: March 16, 2016
Last Verified: March 2016