SureCRIC Standardized Patient Study

Study Overview
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Brief Summary
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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.

Detailed Description
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The study is a two-arm, open-label study involving users - largely licensed paramedics or combat medics - identifying the cricothyroid membranes on healthy volunteers. The Control Group will perform cricothyroid membrane identification on healthy male and female volunteers of varying heights, weights, and BMI's with the standard, freehand approach. The Experimental Group will perform cricothyroid membrane identification on the volunteers with the help of the SureCRIC. An expert verifier (senior otolaryngologist) will verify correct cricothyroid membrane identification and will not be blinded in order to reduce any error that may be introduced by SureCRIC removal and subsequent skin movement. The primary endpoint is a pass/fail assessment for cricothyroid membrane identification. The main secondary endpoint is time to cricothyroid membrane identification. The study design was recommended by FDA. The study, per FDA guidance, is not designed for statistical comparisons and only descriptive statistics are provided.

Official Title
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SureCRIC Standardized Patient Study

Conditions
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Airway Obstruction

Intervention / Treatment
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* Device: SureCRIC
* Other: Freehand


Participation Criteria
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Eligibility Criteria
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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, coagulation disorders such as hemophilia or von Willebrand disease, low or dysfunctional platelets (e.g., thrombocytopenia), leukemia, Cushing's syndrome, Ehlers Danlos syndrome, celiac disease, any condition that causes easy bruising or sensitive or fragile skin. Previous neck surgery, previous neck trauma, thyroid mass or enlargement, or other neck abnormalities Any condition that would make lying supine or without a pillow painful or impossible
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study is a two-arm, open-label study involving users - largely licensed paramedics or combat medics - identifying the cricothyroid membranes on healthy volunteers. The Control Group will perform cricothyroid membrane identification on healthy male and female volunteers of varying heights, weights, and BMI's with the standard, freehand approach. The Experimental Group will perform cricothyroid membrane identification on the volunteers with the help of the SureCRIC.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SureCRIC<br>SureCRIC-aided cricothyroid membrane identification | Device: SureCRIC<br>* 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.<br>|
| Active Comparator: Freehand<br>Freehand cricothyroid membrane identification | Other: Freehand<br>* Freehand palpation approach to identification of the cricothyroid membrane<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Paramedics/Combat Medics Who Accurately Identified the Cricothyroid Membrane on Standardized Patients of Different Sizes | pass/fail assessment for CTM identification as gauged by expert (senior orolaryngologist) | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Cricothyroid Membrane Identification | time to cricothyroid membrane identification as measured by direct observation | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cricothyrotomy