Trial Outcomes & Findings for SureCRIC Standardized Patient Study (NCT NCT03488849)
NCT ID: NCT03488849
Last Updated: 2021-11-23
Results Overview
pass/fail assessment for CTM identification as gauged by expert (senior orolaryngologist)
Recruitment status
COMPLETED
Target enrollment
18 participants
Primary outcome timeframe
1 day
Results posted on
2021-11-23
Participant Flow
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.
Participant milestones
| Measure |
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.
|
Freehand
Freehand cricothyroid membrane identification
Freehand: Freehand palpation approach to identification of the cricothyroid membrane
|
Standardized Patients
Healthy males and females representing the \<10th, 50th and \>90th percentile heights.
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
8
|
6
|
|
Overall Study
COMPLETED
|
10
|
8
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
SureCRIC
n=10 Participants
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.
|
Freehand
n=8 Participants
Freehand cricothyroid membrane identification
Freehand: Freehand palpation approach to identification of the cricothyroid membrane
|
Standardized Patients
n=6 Participants
Healthy male and female volunteers corresponding to the 5th, 50th and 95th percentile heights.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
Between 18-65
|
10 Participants
n=10 Participants
|
8 Participants
n=8 Participants
|
6 Participants
n=6 Participants
|
24 Participants
n=24 Participants
|
|
Sex/Gender, Customized
M or F (not recorded)
|
10 Participants
n=10 Participants
|
8 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
18 Participants
n=24 Participants
|
|
Sex/Gender, Customized
male
|
0 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=6 Participants
|
3 Participants
n=24 Participants
|
|
Sex/Gender, Customized
female
|
0 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=6 Participants
|
3 Participants
n=24 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
First-hand, real-world human performance
|
0 Participants
n=10 Participants
|
3 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=24 Participants
|
|
Human cadaver training
|
1 Participants
n=10 Participants
|
4 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
5 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: 1 dayPopulation: paramedic or combat medic identified cricothyroid membranes on standardized patients as judged by an expert otolaryngologist
pass/fail assessment for CTM identification as gauged by expert (senior orolaryngologist)
Outcome measures
| Measure |
SureCRIC
n=10 Participants
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.
|
Freehand
n=8 Participants
Freehand cricothyroid membrane identification
Freehand: Freehand palpation approach to identification of the cricothyroid membrane
|
Standardized Patient
n=6 Participants
Healthy volunteers - males and females corresponding to the 5th, 50th, and 95th percentile heights
|
|---|---|---|---|
|
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
|
7 Participants
|
NA Participants
participants are identifying the cricothyroid membrane on the 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
|
8 Participants
|
5 Participants
|
NA Participants
participants are identifying the cricothyroid membrane on the 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
|
10 Participants
|
7 Participants
|
NA Participants
participants are identifying the cricothyroid membrane on the 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
|
9 Participants
|
7 Participants
|
NA Participants
participants are identifying the cricothyroid membrane on the 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
|
8 Participants
|
4 Participants
|
NA Participants
participants are identifying the cricothyroid membrane on the 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
|
9 Participants
|
7 Participants
|
NA Participants
participants are identifying the cricothyroid membrane on the standardized patient
|
SECONDARY outcome
Timeframe: 1 dayPopulation: paramedic or combat medic
time to cricothyroid membrane identification as measured by direct observation
Outcome measures
| Measure |
SureCRIC
n=10 Participants
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.
|
Freehand
n=8 Participants
Freehand cricothyroid membrane identification
Freehand: Freehand palpation approach to identification of the cricothyroid membrane
|
Standardized Patient
Healthy volunteers - males and females corresponding to the 5th, 50th, and 95th percentile heights
|
|---|---|---|---|
|
Time to Cricothyroid Membrane Identification
|
34.4 seconds
Standard Deviation 13.4
|
10 seconds
Standard Deviation 7.6
|
—
|
Adverse Events
SureCRIC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Freehand
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standardized Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SureCRIC
n=10 participants at risk
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.
|
Freehand
n=8 participants at risk
Freehand cricothyroid membrane identification
Freehand: Freehand palpation approach to identification of the cricothyroid membrane
|
Standardized Patients
n=6 participants at risk
Healthy volunteers corresponding to the \<10th, 50th and \>90th percentile heights.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
injury including bruising
|
0.00%
0/10 • 1day
standardized patient bruising, injury
|
0.00%
0/8 • 1day
standardized patient bruising, injury
|
0.00%
0/6 • 1day
standardized patient bruising, injury
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place