SureCRIC Standardized Patient Study (NCT03488849) | Clinical Trial Compass
CompletedNot Applicable
SureCRIC Standardized Patient Study
United States18 participantsStarted 2017-10-16
Plain-language summary
SureCRIC is intended to be used as an accessory to cricothyrotomy and tracheotomy devices, helping to identify and stabilize anatomical landmarks for establishing an airway.
Cricothyroid membrane identification accuracy has been reported to be 30-62% in the literature \[Bai15, Ell10, Kri15, Lam15\]. The current study assesses SureCRIC-assisted medic performance in identifying the cricothyroid membrane in a diverse standardized patient population.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Participants (Users):
Inclusion Criteria:
* Paramedic or military combat medic
* Trained to perform a cricothyrotomy
Exclusion Criteria:
* Current or former instructor of cricothyrotomy, airway management, or anatomy
* Experience performing cricothyrotomy on a patient in the last 6 months
* Training on cricothyrotomy in the last 3 months
* Previous or current participation in a study related to cricothyrotomy
* Any condition or physical impairment that limits dexterity and/or tactile feedback
* Performed two or more cricothyrotomies on live humans
* Previous exposure to the SureCRIC
Healthy Volunteers (Standardized Patients):
Inclusion Criteria:
* Less than 10th percentile height female
* 50th percentile height female
* Greater than 90th percentile height female
* Less than 10th percentile height male
* 50th percentile height male
* Greater than 90th percentile height male
Exclusion Criteria:
* Previous exposure to the SureCRIC
* Age under 18 or over 60
* Any skin condition including, but not limited to, eczema and hives
* Skin that is thin, fragile, sensitive and/or prone to redness or irritation including skin that maintains a red, irritated appearance after the light application of pressure
* Easy bruising or use of any blood thinning medication (including aspirin)
* Beard on the neck
* Use of a steroid medication by mouth or in a topical formulation like a cream or ointment
* Any of the following chronic conditions: chronic kidney disease, chronic liver disease, …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Paramedics/Combat Medics Who Accurately Identified the Cricothyroid Membrane on Standardized Patients of Different Sizes