SureCRIC Standardized Patient Study

Airway Obstruction Clinical Trial

Official title:

SureCRIC Standardized Patient Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03488849
• Other study ID #: SureCRIC_SP1
• Secondary ID: W81XWH-14-C-0011
• Status: Completed
• Start date: October 16, 2017
• Est. completion date: October 27, 2017

Study information

• Verified date: October 2021
• Source: InnoVital Systems, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: October 27, 2017
• Est. primary completion date: October 27, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Airway Obstruction

Intervention

Device:
• SureCRIC
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.

Other:
• Freehand
Freehand palpation approach to identification of the cricothyroid membrane

Locations

Country	Name	City	State
United States	National Center for Human Factors in Healthcare	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
InnoVital Systems, Inc.	Medstar Health Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. Erratum in: Anaesthesia. 2010 Dec;65(12):1258. — View Citation

Kristensen MS, Teoh WH, Rudolph SS, Tvede MF, Hesselfeldt R, Børglum 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time to Cricothyroid Membrane Identification	time to cricothyroid membrane identification as measured by direct observation	1 day