Trial Comparing Proximal Tibia and Proximal Humerus Infusion Rates Using the NIO Intraosseous Device
IOACS
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
1 other identifier
interventional
84
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedFirst Posted
Study publicly available on registry
March 7, 2016
CompletedMarch 17, 2016
March 1, 2016
29 days
February 15, 2016
March 16, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Time of IO insertion
1 day
Ease-of-use
1 day
first location
1 day
Study Arms (2)
Proximal tibia
EXPERIMENTALAssumption of intraosseous access into the proximal tibia. Simulation of continous resuscitation was carried out using a system of chest compression LifeLine ARM.
Proximal humerus
EXPERIMENTALAssumption of intraosseous access into the proximal humerus. Simulation of continous resuscitation was carried out using a system of chest compression LifeLine ARM.
Interventions
Eligibility Criteria
You may qualify if:
- give voluntary consent to participate in the study
- paramedics
- without previous experience in intraosseous devices
You may not qualify if:
- not meet the above criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of Warsaw, Department of Emergency Medicine
Warsaw, Masovia, 02-005, Poland
Related Publications (1)
Szarpak L, Truszewski Z, Smereka J, Krajewski P, Fudalej M, Adamczyk P, Czyzewski L. A Randomized Cadaver Study Comparing First-Attempt Success Between Tibial and Humeral Intraosseous Insertions Using NIO Device by Paramedics: A Preliminary Investigation. Medicine (Baltimore). 2016 May;95(20):e3724. doi: 10.1097/MD.0000000000003724.
PMID: 27196493DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 15, 2016
First Posted
March 7, 2016
Study Start
February 1, 2016
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
March 17, 2016
Record last verified: 2016-03