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

Resuscitation Clinical Trial

— IOACS  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02700867
• Other study ID #: 02.006.1MR
• Status: Completed
• Phase: N/A
• First received: February 15, 2016
• Last updated: March 16, 2016
• Start date: February 2016
• Est. completion date: March 2016

Study information

• Verified date: March 2016
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Science and Higher Education
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• give voluntary consent to participate in the study

• paramedics

• without previous experience in intraosseous devices

Exclusion Criteria:

• not meet the above criteria

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intraosseous Access
• Resuscitation

Intervention

Device:
• NIO
Intraosseous access device NIO (Defibtech)

Locations

Country	Name	City	State
Poland	Medical University of Warsaw, Department of Emergency Medicine	Warsaw	Masovia

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	first location	Participants were asked to record their "first location access" tibia or humerus	1 day	No