Ignite Creation Date:
2024-05-06 @ 11:17 AM
Last Modification Date:
2024-10-26 @ 12:43 PM
Study NCT ID:
NCT03488849
Status:
COMPLETED
Last Update Posted:
2021-11-23
First Post:
2018-03-23
Brief Title:
SureCRIC Standardized Patient Study
Sponsor:
InnoVital Systems Inc
Organization:
InnoVital Systems Inc
Study Overview
Official Title:
SureCRIC Standardized Patient Study
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 BMIs 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 passfail 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| W81XWH-14-C-0011 | OTHER | Defense Health Program | None |