SureCRIC Standardized Patient Study

NCT03488849 | Completed Results

• 2 other identifiers: SureCRIC_SP1W81XWH-14-C-0011
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Airway Obstruction

Keywords

cricothyrotomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Time to Cricothyroid Membrane Identification

  1 day

Study Arms (2)

SureCRIC

EXPERIMENTAL

SureCRIC-aided cricothyroid membrane identification

Device: SureCRIC

Freehand

ACTIVE COMPARATOR

Freehand cricothyroid membrane identification

Other: Freehand

Interventions

SureCRIC DEVICE

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.

SureCRIC

Freehand OTHER

Freehand palpation approach to identification of the cricothyroid membrane

Freehand

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Paramedic or military combat medic
• Trained to perform a cricothyrotomy

You may not qualify if:

• 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):
• Less than 10th percentile height female
• th percentile height female
• Greater than 90th percentile height female
• Less than 10th percentile height male
• th percentile height male
• Greater than 90th percentile height male
• Previous exposure to the SureCRIC

Sponsors & Collaborators

• InnoVital Systems, Inc.: lead
• Medstar Health Research Institute: collaborator

Study Sites (1)

National Center for Human Factors in Healthcare

Washington D.C., District of Columbia, 20008, United States

Location

Related 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.

  PMID: 26198864 BACKGROUND

• 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.

  PMID: 20645953 BACKGROUND

• 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.

  PMID: 25991744 BACKGROUND

• 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.

  PMID: 25637060 BACKGROUND

MeSH Terms

Conditions

Airway Obstruction

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: InnoVital Systems

amit@innovitalsystems.com

2022862328

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 23, 2018
• First Posted: April 5, 2018
• Study Start: October 16, 2017
• Primary Completion: October 27, 2017
• Study Completion: October 27, 2017
• Last Updated: November 23, 2021
• Results First Posted: November 23, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)