An interventional study of SureCRIC and Freehand in Airway Obstruction, sponsored by InnoVital Systems, Inc.. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2021-11-23.
Sponsored by InnoVital Systems, Inc. · Interventional and Treatment
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Among 40 studies in Airway Obstruction with a site in United States — 8 open to participants now, 9 under way, none of them phase 3. Airway Obstruction · United States.
Among the 40 studies in Airway Obstruction with a site in United States, this one is the 22nd largest by enrollment of the 29 interventional ones that give a count, is one of 2 that started in 2017, is one of 23 with no phase, and was the 22nd registered.
147 studies on the registry are indexed under Airway Obstruction; 25 are open to participants now.
Browse Airway Obstruction studies →8 of the 40 studies in Airway Obstruction with a site in United States are open now. Recruiting first, the newest first:
Pfizer · Sites in United States, Argentina, Belgium and 12 more countries
Ages 18–75
WellSpan Health · Sites in United States
Ages 18+ · Healthy volunteers
University of Minnesota · Sites in United States
Ages 18+
Brigham and Women's Hospital · Sites in United States
Ages 18+
University of Miami · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 20 Airway Obstruction studies recruiting now, 13 (65%) set no upper age limit and 5 (25%) stop at 75 or younger; 3 take children under 18; 5 take healthy volunteers.
This study: all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
40 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 3 · Phase 3 2 · Phase 4 1
First in 2002; this study’s year is marked. 2 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 18 is below the median of 53 across 92 interventional studies indexed under Airway Obstruction.
Median enrollment 41 across the 29 interventional studies, 168 across the 11 observational. Of the 28 that completed or were terminated, 11 (39%) have results posted.
This tab as a report to print or save as PDF → With an account.
14 of 40 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with InnoVital Systems, Inc. as lead sponsor.
InnoVital Systems, Inc. has 1 study filed under Airway Obstruction — fewer than ten, so there is no comparison to draw.
4 of the studies in Airway Obstruction with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06538376Brigham and Women's HospitalClinical Utility of Portable Dynamic Chest X Ray (DDR) in the ICU | 2026-11 |
| NCT06507670WellSpan HealthPoint of Care Ultrasound for the Detection of Esophageal Food Bolus | 2026-12-31 |
| NCT05881863University of MinnesotaTo Investigate Airway Oxygen Concentrations During Rigid Bronchoscopy Procedures Performed With High Frequency Jet Ventilation | 2026-12-31 |
| NCT06977581PfizerA Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma | 2027-03-08 |
Add all 4 to your calendar (.ics) → With an account.
Among the 40 studies in Airway Obstruction with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Participants (Users):
Inclusion Criteria:
Exclusion Criteria:
Healthy Volunteers (Standardized Patients):
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
SureCRIC-aided cricothyroid membrane identification
Device: SureCRIC
Freehand cricothyroid membrane identification
Other: Freehand
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 palpation approach to identification of the cricothyroid membrane
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
Time to Cricothyroid Membrane Identification
time to cricothyroid membrane identification as measured by direct observation
Time frame: 1 day
| Milestone | SureCRIC | Freehand | Standardized Patients |
|---|---|---|---|
| Started | 10 | 8 | 6 |
| Completed | 10 | 8 | 6 |
| Not completed | 0 | 0 | 0 |
pass/fail assessment for CTM identification as gauged by expert (senior orolaryngologist)
| Participants | SureCRIC | Freehand | Standardized Patient |
|---|---|---|---|
| CTM Identification Success in Less than 10th Percentile Height Female Standardized Patient | 6 | 7 | NA |
| CTM Identification Success in 50th Percentile Height Female Standardized Patient | 8 | 5 | NA |
| CTM Identification Success in Greater than 90th Percentile Height Female Standardized Patient | 10 | 7 | NA |
| CTM Identification Success in Less than 10th Percentile Male Height Standardized Patient | 9 | 7 | NA |
| CTM Identification Success in 50th Percentile Male Height Standardized Patient | 8 | 4 | NA |
| CTM Identification Success in Greater than 90th Percentile Male Height Standardized Patient | 9 | 7 | NA |
time to cricothyroid membrane identification as measured by direct observation
| seconds | SureCRIC | Freehand |
|---|---|---|
| Time to Cricothyroid Membrane Identification | 34.4 ± 13.4 | 10 ± 7.6 |
Collected over 1day. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SureCRIC | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Freehand | 0/6 (0%) | 0/8 (0%) | 0/8 (0%) |
| Standardized Patients | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Event | SureCRIC | Freehand | Standardized Patients |
|---|---|---|---|
| injury including bruisingSkin and subcutaneous tissue disorders | 0/10 | 0/8 | 0/6 |
Participants: Exposure to human cadaver practice (10% of SureCRIC participants vs. 50% of freehand participants); real-world procedural performance (0% of SureCRIC participants vs. 37.5% of freehand participants). Standardized Patients: Healthy volunteers.
| Age, Customized(Participants) | SureCRIC | Freehand | Standardized Patients | Total |
|---|---|---|---|---|
| Between 18-65 | 10 | 8 | 6 | 24 |
| Sex/Gender, Customized(Participants) | SureCRIC | Freehand | Standardized Patients | Total |
|---|---|---|---|---|
| M or F (not recorded) | 10 | 8 | 0 | 18 |
| male | 0 | 0 | 3 | 3 |
| female | 0 | 0 | 3 | 3 |
| Race and Ethnicity Not Collected(Participants) | SureCRIC | Freehand | Standardized Patients | Total |
|---|---|---|---|---|
| Count of participants | — | — | — | 0 |
| First-hand, real-world human performance(Participants) | SureCRIC | Freehand | Standardized Patients | Total |
|---|---|---|---|---|
| Count of participants | 0 | 3 | 0 | 3 |
| Human cadaver training(Participants) | SureCRIC | Freehand | Standardized Patients | Total |
|---|---|---|---|---|
| Count of participants | 1 | 4 | 0 | 5 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Oct 2017 to primary completion in Oct 2017, 0 months.
Results were first posted in Nov 2021, 4 years after primary completion. A results delay was requested in Mar 2019.
Of 44 interventional studies with no phase under Airway Obstruction, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 37. This study's 0 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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