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

Not Applicable

Completed

• Conditions: Intraosseous Access; Resuscitation
• Interventions: Device: NIO

• Registration Number: NCT02700867
• Lead Sponsor: Medical University of Warsaw

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 Description

Not available

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-15
• Status Verified: 2016-03
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Study First Submitted QC: 2016-03-03
• Study First Posted: 2016-03-07
• Last Update Submitted: 2016-03-16
• Last Update Posted: 2016-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Proximal humerus	NIO	Assumption of intraosseous access into the proximal humerus. Simulation of continous resuscitation was carried out using a system of chest compression LifeLine ARM.
Proximal tibia	NIO	Assumption of intraosseous access into the proximal tibia. Simulation of continous resuscitation was carried out using a system of chest compression LifeLine ARM.

Primary Outcome Measures

Name	Time	Method
Success rate	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 Outcome Measures

Name	Time	Method
Time of IO insertion	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	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	1 day	Participants were asked to record their "first location access" tibia or humerus

Trial Locations

Locations (1)

Medical University of Warsaw, Department of Emergency Medicine; 🇵🇱 Warsaw, Masovia, Poland