NCT03488849

SureCRIC Standardized Patient Study

• Status: Completed
• Phase: —
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: InnoVital Systems, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Airway Obstruction

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-10-16
• Primary completion: 2017-10-27
• Completion: 2017-10-27
• First posted: 2018-04-05
• Last updated: 2021-11-23
• Results posted: 2021-11-23

Locations

1 site across 1 country: United States