Airway MorbidityAirway-to-GoNCT07076511
A Novel Intuitive Airway Trolley for Quick Decision-making in Simulated Unexpected Difficult Airway Situations: Evaluation and Comparison to the Existing Airway Trolley
A study testing Scenario "unexpected difficult airway" in people with Airway Morbidity and Team Efficacy, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial summary
The goal of this study is to analyze the impact of color-coded labeling and cognitive visual aids of a novel airway trolley on the performance of participants in a simulated unexpected difficult airway scenario. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Airway Morbidity, Team Efficacy, Intubation; Difficult or Failed
- What is being tested?
- Scenario "unexpected difficult airway"
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2025to 11 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- anaesthesiological 2nd and 3rd year residents at University Medical Centre Mainz
- anaesthesiological attendings at University Medical Centre Mainz
- informed written consent
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anaesthesiology, University Medical Centre of Johannes Gutenberg University
Mainz, Rhineland-Palatine, 55131
About this study
Official title: A Novel, Intuitive Airway Trolley to Facilitate Fast Decision Making in the Emergency Scenario "Unexpected Difficult Airway": Evaluation and Comparison to the Existing Airway Trolley in the Scope of a Simulation Training
The goal of this study is to analyze the impact of color-coded labeling and cognitive visual aids of a novel airway trolley on the performance of participants in a simulated unexpected difficult airway scenario. All participants will complete the same scenario, randomized to either the novel or the existing airway trolley. The main questions aimed to be answered are:
- how long does it take to solve the scenario (=establish sufficient oxygenation via emergency front of neck access) with the novel vs the existing airway trolley?
- how many deviations from the algorithm "unexpected difficult airway" are documented for each trolley (novel vs existing)?
- are there differences in the provider experience between both trolleys
- Being tested
- Scenario "unexpected difficult airway"
- Keywords
- Difficult Airway Trolley, Human factors, Team performance, visual aids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scenario "unexpected difficult airway"Other
Participants are asked to solve a scenario "unexpected difficult airway" using a manikin in accordance with current guidelines. The scenario aims for participants to try 3 different techniques in securing the airway before performing emergency front of neck access.
| Study group | Role | What they receive |
|---|---|---|
| Novel Airway Trolley | Active comparator | Participants are asked to solve a scenario "unexpected difficult airway" using the novel Airway Trolley with color-coding and visual aids Receives: Other: Scenario "unexpected difficult airway" |
| Existing Airway Trolley | Placebo comparator | Participants are asked to solve a scenario "unexpected difficult airway" using the existing Airway Trolley without color-coding and visual aids Receives: Other: Scenario "unexpected difficult airway" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to emergency front of neck access (eFONA) decision (in s)
time to verbalized decision to perform eFONA defined as time to solving the scenario (in s)
Measured: time (in seconds) until scenario is solved and decision to perform eFONA is verbalized (maximum time to solve scenario 10 minutes)
Secondary outcomes (8)
Time to decision to prepare eFONA (in sec)
Time until the decision to prepare (but not directly execute) eFONA (in sec)
Measured: time (in seconds) when decision to prepare eFONA is verbalized (maximum time to solve scenario 10 minutes)
Time to establish successful oxygenation (in seconds)
Time to establish successful oxygenation (defined as successfully conducting eFONA and performing ventilation) in seconds
Measured: Maximum time to solve scenario: 10 minutes
number of departures from difficult airway algorithm
The number of times during the scenario that the treatment is not concordant with the difficult airway algorithm
Measured: Through the course of the scenario (maximum time for completion 10 minutes)
Gender differences in the time until eFONA
Gender differences in the time until eFONA is performed
Measured: Maximum time to solve the scenario: 10 minutes
Gender differences in number of departures from difficult airway algorithm
Gender differences in number of departures from difficult airway algorithm
Measured: Maximum time to solve the scenario: 10 minutes
subjective work load evaluation
evaluating the work load using NASA task load scale (NASA-TLX) questionnaire (nominal scale from very low to very high)
Measured: To be filled out after completing the scenario (time given: 3 minutes)
number of unnecessary drawer opening
The number of times during the scenario that drawers are opened without retrieving any equipment
Measured: Through the course of the scenario (maximum time for completion 10 minutes)
subjective operator experience
Experience of the operator using an ordinal scale (1-7)
Measured: To be filled out after completing the scenario (time given: 3 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start1 Jul 2025
- Primary completion11 Jul 2025
- Study completion11 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway MorbidityStudies 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
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, controlled, single-blinded simulation study
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katharina Epp, Johannes Gutenberg University Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07076511
- Sponsor's protocol ID
- Airway-to-Go
- Acronym
- Airway-to-Go
- Status last verified
- Jul 2025
- First submitted
- 16 Jul 2023
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel, Intuitive Airway Trolley to Facilitate Fast Decision Making in the Emergency Scenario "Unexpected Difficult Airway": Evaluation and Comparison to the Existing Airway Trolley in the Scope of a Simulation Training
- ClinicalTrials.gov ID
- NCT07076511
- Acronym / sponsor ID
- Airway-to-Go / Airway-to-Go
- Keywords
- Difficult Airway Trolley, Human factors, Team performance, visual aids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 11 Jul 2025 (actual)
- Study completion
- 11 Jul 2025 (actual)
- First posted
- 22 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to analyze the impact of color-coded labeling and cognitive visual aids of a novel airway trolley on the performance of participants in a simulated unexpected difficult airway scenario. All participants will complete the same scenario, randomized to either the novel or the existing airway trolley. The main questions aimed to be answered are:
- how long does it take to solve the scenario (=establish sufficient oxygenation via emergency front of neck access) with the novel vs the existing airway trolley?
- how many deviations from the algorithm "unexpected difficult airway" are documented for each trolley (novel vs existing)?
- are there differences in the provider experience between both trolleys
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized, controlled, single-blinded simulation study
| Arm | Type | Receives |
|---|---|---|
| Novel Airway Trolley | Active comparator | Other: Scenario "unexpected difficult airway"Participants are asked to solve a scenario "unexpected difficult airway" using the novel Airway Trolley with color-coding and visual aids |
| Existing Airway Trolley | Placebo comparator | Other: Scenario "unexpected difficult airway"Participants are asked to solve a scenario "unexpected difficult airway" using the existing Airway Trolley without color-coding and visual aids |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- anaesthesiological 2nd and 3rd year residents at University Medical Centre Mainz
- anaesthesiological attendings at University Medical Centre Mainz
- informed written consent
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Scenario "unexpected difficult airway"Participants are asked to solve a scenario "unexpected difficult airway" using a manikin in accordance with current guidelines. The scenario aims for participants to try 3 different techniques in securing the airway before performing emergency front of neck access. | Other | Existing Airway Trolley, Novel Airway Trolley |
Primary outcome
Time to emergency front of neck access (eFONA) decision (in s)
Time frame: time (in seconds) until scenario is solved and decision to perform eFONA is verbalized (maximum time to solve scenario 10 minutes)
time to verbalized decision to perform eFONA defined as time to solving the scenario (in s)
8 secondary outcomes
Time to decision to prepare eFONA (in sec)
Time frame: time (in seconds) when decision to prepare eFONA is verbalized (maximum time to solve scenario 10 minutes)
Time to establish successful oxygenation (in seconds)
Time frame: Maximum time to solve scenario: 10 minutes
number of departures from difficult airway algorithm
Time frame: Through the course of the scenario (maximum time for completion 10 minutes)
Gender differences in the time until eFONA
Time frame: Maximum time to solve the scenario: 10 minutes
Gender differences in number of departures from difficult airway algorithm
Time frame: Maximum time to solve the scenario: 10 minutes
subjective work load evaluation
Time frame: To be filled out after completing the scenario (time given: 3 minutes)
number of unnecessary drawer opening
Time frame: Through the course of the scenario (maximum time for completion 10 minutes)
subjective operator experience
Time frame: To be filled out after completing the scenario (time given: 3 minutes)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Individual participant dataSharing planned: Undecided
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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 Scenario "unexpected difficult airway" in people with Airway Morbidity and Team Efficacy, run by Johannes Gutenberg University Mainz at 1 site in Germany.
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 3 inclusion and 0 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 22 Jul 2025. 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 Germany. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to emergency front of neck access (eFONA) decision (in s) (time frame: time (in seconds) until scenario is solved and decision to perform eFONA is verbalized (maximum time to solve scenario 10 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jul 2025.