SureCRIC Standardized Patient Study

Status Completed

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Airway Obstruction

Clinical Trial Details

NCT number	NCT03488849
Study type	Interventional
Source	InnoVital Systems, Inc.
Contact
Status	Completed
Phase
Start date	October 16, 2017
Completion date	October 27, 2017

View Details

See also
Status	Clinical Trial	Phase
Enrolling by invitation	`NCT04506346` - Risk Prediction of Difficult Tracheal Intubation in OSAHS Patient
Completed	`NCT02106143` - RejuvenAir™ System Lobectomy Safety and Histology Study	N/A
Completed	`NCT03274791` - Clinical Features and Airways Inflammation in Never Smokers and Smokers With COPD	N/A
Completed	`NCT01765530` - Efficacy Study of a Novel Device to Clean the Endotracheal Tube	N/A
Completed	`NCT01721486` - Acetaminophen's Efficacy For Post-operative Pain	Phase 4
Completed	`NCT03656315` - Scoring System to Predict Depth of Cricothyroid Membrane	N/A
Recruiting	`NCT05880836` - In Line Aerosol Nebulization With High Flow	N/A
Recruiting	`NCT05573919` - VivAer: A Correlation Between Symptom Scores and Objective Findings	N/A
Completed	`NCT02403934` - Jaw Elevation Device in Deep Sedation Study	N/A
Recruiting	`NCT00452062` - Dexamethasone and the Prevention of Post-Extubation Airway Obstruction in Adults	Phase 2
Completed	`NCT02563210` - Airway Resistance Measurement in Children 3 to 6 Years of Age	N/A
Completed	`NCT03752593` - The Incidence of Difficult Intubation in Obese Versus Non-obese Patients
Recruiting	`NCT05974488` - The Efficacy of Distal Pharyngeal Airway for Oxygenation During TEE	N/A
Not yet recruiting	`NCT02975791` - Ultrasonography Versus Palpation for Identification of the Cricothyroid Membrane	N/A
Completed	`NCT00788788` - Heliox in Experimental Upper Airway Obstruction	Phase 1/Phase 2
Not yet recruiting	`NCT06128811` - Dental Isolation Systems Among Pediatric Patients With Different Airway Patency	N/A
Completed	`NCT05550220` - A Modified Cuff Leak Test and Reintubation in Mechanically Ventilated Patients	N/A
Completed	`NCT03165461` - Evaluation of the Use of Tracheal Intubation Through a Laryngeal Tube to Intubate Anesthetized Patients
Recruiting	`NCT03969147` - Investigation of a Novel Oropharyngeal Airway: The ManMaxAirway	N/A
Completed	`NCT03604055` - Can Recurrence of Hamartomas be Prevented?	N/A