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

Medical University of Warsaw84 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Intraosseous Access Resuscitation

Interventions

NIODEVICE

Intraosseous access device NIO (Defibtech)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Medical University of Warsaw, Department of Emergency Medicine

Warsaw, Masovia, Poland

Outcomes

Primary Outcomes

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.

Time frame: 1 day

Secondary Outcomes

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.

Time frame: 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).

Time frame: 1 day

first location

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

Time frame: 1 day

Data from ClinicalTrials.gov

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