Airway ObstructionNCT03488849
SureCRIC Standardized Patient Study
A study testing SureCRIC and Freehand in people with Airway Obstruction, run by InnoVital Systems, Inc. at 1 site in United States.
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]. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Airway Obstruction
- What is being tested?
- SureCRIC and Freehand
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2017to 27 Oct 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Paramedic or military combat medic
- Trained to perform a cricothyrotomy
- 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
Who cannot join
- 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
Show all 18Show fewer
- Previous exposure to the SureCRIC
- Healthy Volunteers (Standardized Patients):
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
National Center for Human Factors in Healthcare
Washington D.C., District of Columbia, 20008
About this study
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.
Read the 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.
- Conditions
- Airway Obstruction
- Being tested
- SureCRIC, Freehand
- Keywords
- cricothyrotomy
- Medical subject headings
- Airway Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SureCRICDevice
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.
FreehandOther
Freehand palpation approach to identification of the cricothyroid membrane
| Study group | Role | What they receive |
|---|---|---|
| SureCRIC | Experimental | SureCRIC-aided cricothyroid membrane identification Receives: Device: SureCRIC |
| Freehand | Active comparator | Freehand cricothyroid membrane identification Receives: Other: Freehand |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 day
Secondary outcomes (1)
Time to Cricothyroid Membrane Identification
time to cricothyroid membrane identification as measured by direct observation
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study start16 Oct 2017
- Primary completion27 Oct 2017
- Study completion27 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Airway ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- InnoVital Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medstar Health Research Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03488849
- Sponsor's protocol ID
- SureCRIC_SP1
- Other IDs
- W81XWH-14-C-0011
- Status last verified
- Oct 2021
- First submitted
- 23 Mar 2018
- Last updated
- 23 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bair AE, Chima R. The inaccuracy of using landmark techniques for cricothyroid membrane identification: a comparison of three techniques. Acad Emerg Med. 2015 Aug;22(8):908-14. doi: 10.1111/acem.12732. Epub 2015 Jul 21.
PubMed 26198864Elliott DS, Baker PA, Scott MR, Birch CW, Thompson JM. Accuracy of surface landmark identification for cannula cricothyroidotomy. Anaesthesia. 2010 Sep;65(9):889-94. doi: 10.1111/j.1365-2044.2010.06425.x.
PubMed 20645953Kristensen MS, Teoh WH, Rudolph SS, Tvede MF, Hesselfeldt R, Borglum J, Lohse T, Hansen LN. Structured approach to ultrasound-guided identification of the cricothyroid membrane: a randomized comparison with the palpation method in the morbidly obese. Br J Anaesth. 2015 Jun;114(6):1003-4. doi: 10.1093/bja/aev123. No abstract available.
PubMed 25991744Lamb A, Zhang J, Hung O, Flemming B, Mullen T, Bissell MB, Arseneau I. Accuracy of identifying the cricothyroid membrane by anesthesia trainees and staff in a Canadian institution. Can J Anaesth. 2015 May;62(5):495-503. doi: 10.1007/s12630-015-0326-y. Epub 2015 Jan 31.
PubMed 25637060
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SureCRIC Standardized Patient Study
- ClinicalTrials.gov ID
- NCT03488849
- Acronym / sponsor ID
- SureCRIC_SP1
- Conditions
- Airway Obstruction
- Keywords
- cricothyrotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- InnoVital Systems, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Medstar Health Research Institute
- Study start
- 16 Oct 2017 (actual)
- Primary completion
- 27 Oct 2017 (actual)
- Study completion
- 27 Oct 2017 (actual)
- First posted
- 5 Apr 2018 (actual)
- Results
- Posted 23 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| SureCRIC | Experimental | Device: SureCRICSureCRIC-aided cricothyroid membrane identification |
| Freehand | Active comparator | Other: FreehandFreehand cricothyroid membrane identification |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Paramedic or military combat medic
- Trained to perform a cricothyrotomy
- Less than 10th percentile height female
- 50th percentile height female
- Greater than 90th percentile height female
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SureCRICSureCRIC is intended to be used as an accessory to cricothyrotomy and tracheotomy devices, helping to identify and stabilize anatomical landmarks for establishing an airway. | Device | SureCRIC |
| FreehandFreehand palpation approach to identification of the cricothyroid membrane | Other | Freehand |
Primary outcome
Number of Paramedics/Combat Medics Who Accurately Identified the Cricothyroid Membrane on Standardized Patients of Different Sizes
Time frame: 1 day
pass/fail assessment for CTM identification as gauged by expert (senior orolaryngologist)
1 secondary outcome
Time to Cricothyroid Membrane Identification
Time frame: 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26198864Bair AE, Chima R. The inaccuracy of using landmark techniques for cricothyroid membrane identification: a comparison of three techniques. Acad Emerg Med. 2015 Aug;22(8):908-14. doi: 10.1111/acem.12732. Epub 2015 Jul 21.
- Background: PubMed 20645953Elliott DS, Baker PA, Scott MR, Birch CW, Thompson JM. Accuracy of surface landmark identification for cannula cricothyroidotomy. Anaesthesia. 2010 Sep;65(9):889-94. doi: 10.1111/j.1365-2044.2010.06425.x.
- Background: PubMed 25991744Kristensen MS, Teoh WH, Rudolph SS, Tvede MF, Hesselfeldt R, Borglum J, Lohse T, Hansen LN. Structured approach to ultrasound-guided identification of the cricothyroid membrane: a randomized comparison with the palpation method in the morbidly obese. Br J Anaesth. 2015 Jun;114(6):1003-4. doi: 10.1093/bja/aev123. No abstract available.
- Background: PubMed 25637060Lamb A, Zhang J, Hung O, Flemming B, Mullen T, Bissell MB, Arseneau I. Accuracy of identifying the cricothyroid membrane by anesthesia trainees and staff in a Canadian institution. Can J Anaesth. 2015 May;62(5):495-503. doi: 10.1007/s12630-015-0326-y. Epub 2015 Jan 31.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SureCRIC and Freehand in people with Airway Obstruction, run by InnoVital Systems, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Paramedics/Combat Medics Who Accurately Identified the Cricothyroid Membrane on Standardized Patients of Different Sizes (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03488849, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2021.