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
SexALL
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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, …
What they're measuring
1
Number of Paramedics/Combat Medics Who Accurately Identified the Cricothyroid Membrane on Standardized Patients of Different Sizes