SureCRIC Standardized Patient Study

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.

Study Overview

• Status: Completed
• Conditions: Airway Obstruction
• Intervention / Treatment: Device: SureCRIC; Other: Freehand

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.

• Study Type: Interventional
• Enrollment (Actual): 18

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20008
      • National Center for Human Factors in Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SureCRIC; SureCRIC-aided cricothyroid membrane identification	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.
Active Comparator: Freehand; Freehand cricothyroid membrane identification	Other: Freehand; Freehand palpation approach to identification of the cricothyroid membrane

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: InnoVital Systems, Inc.
• Collaborators: Medstar Health Research Institute

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2017
• Primary Completion (Actual): October 27, 2017
• Study Completion (Actual): October 27, 2017

Study Registration Dates

• First Submitted: March 23, 2018
• First Submitted That Met QC Criteria: April 4, 2018
• First Posted (Actual): April 5, 2018

Study Record Updates

• Last Update Posted (Actual): November 23, 2021
• Last Update Submitted That Met QC Criteria: October 26, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: cricothyrotomy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency; Airway Obstruction
• Other Study ID Numbers: SureCRIC_SP1; W81XWH-14-C-0011 (Other Identifier: Defense Health Program)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No