Airway Obstruction
Conditions
Keywords
cricothyrotomy
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.
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.
Interventions
DEVICESureCRIC
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.
OTHERFreehand
Freehand palpation approach to identification of the cricothyroid membrane
Sponsors
Medstar Health Research Institute
InnoVital Systems, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model 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.
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Paramedics/Combat Medics Who Accurately Identified the Cricothyroid Membrane on Standardized Patients of Different Sizes | 1 day | pass/fail assessment for CTM identification as gauged by expert (senior orolaryngologist) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Cricothyroid Membrane Identification | 1 day | time to cricothyroid membrane identification as measured by direct observation |
Countries
United States
Participant flow
Pre-assignment details
We aimed to include 2 groups of 10 participants. One group for the SureCRIC arm and one group for the freehand arm. 12 participants/group were recruited to fill this quota. Ultimately, 10 participants were included in the SureCRIC arm and 8 in the freehand arm due to no-shows/cancellations. The 18 participants represented novice target end users: paramedics & military medics. Each of the 18 participants tested on 6 healthy standardized patients: M's & F's of \<10th, 50th & \>90th %ile heights.
Participants by arm
| Arm | Count |
|---|---|
| SureCRIC SureCRIC-aided cricothyroid membrane identification
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. | 10 |
| Freehand Freehand cricothyroid membrane identification
Freehand: Freehand palpation approach to identification of the cricothyroid membrane | 8 |
| Standardized Patients Healthy male and female volunteers corresponding to the 5th, 50th and 95th percentile heights. | 6 |
| Total | 24 |
Baseline characteristics
| Characteristic | SureCRIC | Freehand | Standardized Patients | Total |
|---|---|---|---|---|
| Age, Customized Between 18-65 | 10 Participants | 8 Participants | 6 Participants | 24 Participants |
| First-hand, real-world human performance | 0 Participants | 3 Participants | 0 Participants | 3 Participants |
| Human cadaver training | 1 Participants | 4 Participants | 0 Participants | 5 Participants |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Sex/Gender, Customized female | 0 Participants | 0 Participants | 3 Participants | 3 Participants |
| Sex/Gender, Customized male | 0 Participants | 0 Participants | 3 Participants | 3 Participants |
| Sex/Gender, Customized M or F (not recorded) | 10 Participants | 8 Participants | 0 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 0 / 10 | 0 / 8 | 0 / 6 |
| serious Total, serious adverse events | 0 / 10 | 0 / 8 | 0 / 6 |
Outcome results
Primary
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)
Time frame: 1 day
Population: paramedic or combat medic identified cricothyroid membranes on standardized patients as judged by an expert otolaryngologist
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SureCRIC | Number of Paramedics/Combat Medics Who Accurately Identified the Cricothyroid Membrane on Standardized Patients of Different Sizes | CTM Identification Success in Less than 10th Percentile Height Female Standardized Patient | 6 Participants |
| SureCRIC | Number of Paramedics/Combat Medics Who Accurately Identified the Cricothyroid Membrane on Standardized Patients of Different Sizes | CTM Identification Success in 50th Percentile Height Female Standardized Patient | 8 Participants |
| SureCRIC | Number of Paramedics/Combat Medics Who Accurately Identified the Cricothyroid Membrane on Standardized Patients of Different Sizes | CTM Identification Success in Greater than 90th Percentile Height Female Standardized Patient | 10 Participants |
| SureCRIC | Number of Paramedics/Combat Medics Who Accurately Identified the Cricothyroid Membrane on Standardized Patients of Different Sizes | CTM Identification Success in Less than 10th Percentile Male Height Standardized Patient | 9 Participants |
| SureCRIC | Number of Paramedics/Combat Medics Who Accurately Identified the Cricothyroid Membrane on Standardized Patients of Different Sizes | CTM Identification Success in 50th Percentile Male Height Standardized Patient | 8 Participants |
| SureCRIC | Number of Paramedics/Combat Medics Who Accurately Identified the Cricothyroid Membrane on Standardized Patients of Different Sizes | CTM Identification Success in Greater than 90th Percentile Male Height Standardized Patient | 9 Participants |
| Freehand | Number of Paramedics/Combat Medics Who Accurately Identified the Cricothyroid Membrane on Standardized Patients of Different Sizes | CTM Identification Success in Greater than 90th Percentile Male Height Standardized Patient | 7 Participants |
| Freehand | Number of Paramedics/Combat Medics Who Accurately Identified the Cricothyroid Membrane on Standardized Patients of Different Sizes | CTM Identification Success in Less than 10th Percentile Height Female Standardized Patient | 7 Participants |
| Freehand | Number of Paramedics/Combat Medics Who Accurately Identified the Cricothyroid Membrane on Standardized Patients of Different Sizes | CTM Identification Success in Less than 10th Percentile Male Height Standardized Patient | 7 Participants |
| Freehand | Number of Paramedics/Combat Medics Who Accurately Identified the Cricothyroid Membrane on Standardized Patients of Different Sizes | CTM Identification Success in 50th Percentile Male Height Standardized Patient | 4 Participants |
| Freehand | Number of Paramedics/Combat Medics Who Accurately Identified the Cricothyroid Membrane on Standardized Patients of Different Sizes | CTM Identification Success in 50th Percentile Height Female Standardized Patient | 5 Participants |
| Freehand | Number of Paramedics/Combat Medics Who Accurately Identified the Cricothyroid Membrane on Standardized Patients of Different Sizes | CTM Identification Success in Greater than 90th Percentile Height Female Standardized Patient | 7 Participants |
| Standardized Patient | Number of Paramedics/Combat Medics Who Accurately Identified the Cricothyroid Membrane on Standardized Patients of Different Sizes | CTM Identification Success in 50th Percentile Height Female Standardized Patient | NA Participants |
| Standardized Patient | Number of Paramedics/Combat Medics Who Accurately Identified the Cricothyroid Membrane on Standardized Patients of Different Sizes | CTM Identification Success in Greater than 90th Percentile Height Female Standardized Patient | NA Participants |
| Standardized Patient | Number of Paramedics/Combat Medics Who Accurately Identified the Cricothyroid Membrane on Standardized Patients of Different Sizes | CTM Identification Success in Greater than 90th Percentile Male Height Standardized Patient | NA Participants |
| Standardized Patient | Number of Paramedics/Combat Medics Who Accurately Identified the Cricothyroid Membrane on Standardized Patients of Different Sizes | CTM Identification Success in Less than 10th Percentile Male Height Standardized Patient | NA Participants |
| Standardized Patient | Number of Paramedics/Combat Medics Who Accurately Identified the Cricothyroid Membrane on Standardized Patients of Different Sizes | CTM Identification Success in Less than 10th Percentile Height Female Standardized Patient | NA Participants |
| Standardized Patient | Number of Paramedics/Combat Medics Who Accurately Identified the Cricothyroid Membrane on Standardized Patients of Different Sizes | CTM Identification Success in 50th Percentile Male Height Standardized Patient | NA Participants |
Secondary
Time to Cricothyroid Membrane Identification
time to cricothyroid membrane identification as measured by direct observation
Time frame: 1 day
Population: paramedic or combat medic
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SureCRIC | Time to Cricothyroid Membrane Identification | 34.4 seconds | Standard Deviation 13.4 |
| Freehand | Time to Cricothyroid Membrane Identification | 10 seconds | Standard Deviation 7.6 |