N/A
N=24
SureCRIC Standardized Patient Study
Airway Obstruction
Bottom Line
View on ClinicalTrials.gov: NCT03488849 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcome: Primary: Number of Paramedics/Combat Medics Who Accurately Identified the Cricothyroid Membrane on Standardized Patients of Different Sizes — 6; 7; NA; 8 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SureCRIC (Device); Freehand (Other)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- InnoVital Systems, Inc.
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Paramedics/Combat Medics Who Accurately Identified the Cricothyroid Membrane on Standardized Patients of Different Sizes |
6; 7; NA; 8; 5; NA | — |
| SECONDARY Time to Cricothyroid Membrane Identification |
34.4; 10 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03488849). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.