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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Intraosseous Access, Resuscitation

Intervention / Treatment
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* Device: NIO


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: give voluntary consent to participate in the study paramedics without previous experience in intraosseous devices Exclusion Criteria: not meet the above criteria

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Proximal tibia<br>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<br>* Intraosseous access device NIO (Defibtech)<br>|
| Experimental: Proximal humerus<br>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<br>* Intraosseous access device NIO (Defibtech)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). | 1 day | 
| first location | Participants were asked to record their first location access tibia or humerus | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intraosseous access, cardiopulmonary resuscitation, paramedic, simulation, cadaver