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SureCRIC Standardized Patient Study

Primary Purpose

Airway Obstruction

Status
Completed
Phase
Locations
United States
Study Type
Interventional
Intervention
SureCRIC
Freehand
Sponsored by
InnoVital Systems, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Airway Obstruction focused on measuring cricothyrotomy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • National Center for Human Factors in Healthcare

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SureCRIC

Freehand

Arm Description

SureCRIC-aided cricothyroid membrane identification

Freehand cricothyroid membrane identification

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Time to Cricothyroid Membrane Identification
time to cricothyroid membrane identification as measured by direct observation

Full Information

First Posted
March 23, 2018
Last Updated
October 26, 2021
Sponsor
InnoVital Systems, Inc.
Collaborators
Medstar Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03488849
Brief Title
SureCRIC Standardized Patient Study
Official Title
SureCRIC Standardized Patient Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
October 16, 2017 (Actual)
Primary Completion Date
October 27, 2017 (Actual)
Study Completion Date
October 27, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
InnoVital Systems, Inc.
Collaborators
Medstar Health Research Institute

4. Oversight

Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Airway Obstruction
Keywords
cricothyrotomy

7. Study Design

Primary Purpose
Treatment
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SureCRIC
Arm Type
Experimental
Arm Description
SureCRIC-aided cricothyroid membrane identification
Arm Title
Freehand
Arm Type
Active Comparator
Arm Description
Freehand cricothyroid membrane identification
Intervention Type
Device
Intervention Name(s)
SureCRIC
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Freehand
Intervention Description
Freehand palpation approach to identification of the cricothyroid membrane
Primary Outcome Measure Information:
Title
Number of Paramedics/Combat Medics Who Accurately Identified the Cricothyroid Membrane on Standardized Patients of Different Sizes
Description
pass/fail assessment for CTM identification as gauged by expert (senior orolaryngologist)
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Time to Cricothyroid Membrane Identification
Description
time to cricothyroid membrane identification as measured by direct observation
Time Frame
1 day

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
National Center for Human Factors in Healthcare
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20008
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26198864
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.
Results Reference
background
PubMed Identifier
20645953
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.
Results Reference
background
PubMed Identifier
25991744
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.
Results Reference
background
PubMed Identifier
25637060
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.
Results Reference
background

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SureCRIC Standardized Patient Study

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