SureCRIC Standardized Patient Study

InnoVital Systems

Status

Completed

Conditions

Airway Obstruction

Treatments

Device: SureCRIC

Other: Freehand

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03488849

SureCRIC_SP1

W81XWH-14-C-0011 (Other Identifier)

Details and patient eligibility

About

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.

Full 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. 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.

Enrollment

18 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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