Supraglottic Airways for Entrapped Trauma Patients
Supraglottic Airway Devices for Airway Management of Entrapped Trauma Patients - an Evaluation of Four Devices in a Simulated Condition With Simultaneous Cervical Spine Immobilisation - a Randomised, Controlled Trial
1 other identifier
interventional
50
1 country
1
Brief Summary
The aim of this clinical trial is to evaluate four supraglottic airway devices for ventilation in a simulated condition of an entrapped trauma patient with simultaneous cervical spine immobilisation. All the studied devices are evaluated by fully-qualified and experienced paramedics (both male and female). The main questions it aims to answer are:
- 1.Which device requires the shortest time required to achieve a successful ventilation?
- 2.What is the first attempt success rate of the studied devices?
- 3.Which device is the easiest to use and the most user-friendly? Study participants will evaluate four different supraglottic devices in a restricted access to the entrapped trauma patient's airway. The maximum number of insertion attempts is limited to three per device.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2024
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
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2024
CompletedFirst Submitted
Initial submission to the registry
July 16, 2024
CompletedFirst Posted
Study publicly available on registry
August 9, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2025
CompletedMay 6, 2025
May 1, 2025
2 months
July 16, 2024
May 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Successful ventilation time
The time required to insert the device and achieve a successful ventilation
During procedure: 120 seconds
Secondary Outcomes (2)
First attempt success rate of ventilation
During procedure: 120 seconds
The ease of use and user-friendliness
During procedure: 120 seconds
Study Arms (2)
LMA Supreme Group
ACTIVE COMPARATORParamedics using the LMA Supreme airway device
Other Supraglottic Airway Group
EXPERIMENTALParamedics using other supraglottic devices
Interventions
Eligibility Criteria
You may qualify if:
- fully-qualified paramedics
- at least four years of practice after finishing paramedic training
- active (working) paramedics
You may not qualify if:
- paramedics in training
- retired paramedics
- lack of written informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Radom
Radom, Masovian Voivodeship, 26-600, Poland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dawid J Aleksandrowicz, PhD
University of Radom
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2024
First Posted
August 9, 2024
Study Start
July 1, 2024
Primary Completion
September 1, 2024
Study Completion
May 1, 2025
Last Updated
May 6, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share