Clinical trial NCT03488849: SureCRIC Standardized Patient Study
Official title: SureCRIC Standardized Patient Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Conditions: Airway Obstruction
Keywords: cricothyrotomy
Lead sponsor: InnoVital Systems, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Medstar Health Research Institute
First posted: 2018-04-05
Enrollment: 18
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Number of Paramedics/Combat Medics Who Accurately Identified the Cricothyroid Membrane on Standardized Patients of Different Sizes
timeFrame: 1 day
Secondary outcomes:
measure: Time to Cricothyroid Membrane Identification
timeFrame: 1 day
Other outcomes:
Locations:
city: Washington
country: United States
facility: National Center for Human Factors in Healthcare
state: District of Columbia
Study officials:
References:
citation: Bair AE, Chima R. The inaccuracy of using landmark techniques for cricothyroid membrane identification: a comparison of three techniques. Acad Emerg Med. 2015 Aug;22(8):908-14. doi: 10.1111/acem.12732. Epub 2015 Jul 21.
citation: Elliott DS, Baker PA, Scott MR, Birch CW, Thompson JM. Accuracy of surface landmark identification for cannula cricothyroidotomy. Anaesthesia. 2010 Sep;65(9):889-94. doi: 10.1111/j.1365-2044.2010.06425.x.
citation: Kristensen MS, Teoh WH, Rudolph SS, Tvede MF, Hesselfeldt R, Borglum J, Lohse T, Hansen LN. Structured approach to ultrasound-guided identification of the cricothyroid membrane: a randomized comparison with the palpation method in the morbidly obese. Br J Anaesth. 2015 Jun;114(6):1003-4. doi: 10.1093/bja/aev123. No abstract available.
citation: Lamb A, Zhang J, Hung O, Flemming B, Mullen T, Bissell MB, Arseneau I. Accuracy of identifying the cricothyroid membrane by anesthesia trainees and staff in a Canadian institution. Can J Anaesth. 2015 May;62(5):495-503. doi: 10.1007/s12630-015-0326-y. Epub 2015 Jan 31.