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Completed

NCT Number: NCT02700867

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

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.

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Key information

Conditions

Intraosseous Access Cadaver Death Pathologic Processes Pathological Conditions, Signs and Symptoms Resuscitation

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Warsaw, Department of Emergency Medicine

Warsaw, Masovia, 02-005, Poland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • give voluntary consent to participate in the study
  • paramedics
  • without previous experience in intraosseous devices

Exclusion criteria

  • not meet the above criteria

Treatment and study plan

NIO

Device

Intraosseous access device NIO (Defibtech)

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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).

  3. first location

    Time frame: 1 day

    Participants were asked to record their "first location access" tibia or humerus

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Official study title

A Randomized Crossover Cadaver Trial Comparing Proximal Tibia and Proximal Humerus Infusion Rates Using the NIO Intraosseous Device During Simulated Cardiopulmonary Resuscitation Performed by Paramedics

Acronym: IOACS

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 7, 2016
Registry last updated
Mar 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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