Airway ManagementTemplateAirwayNCT06400693
Templates as Cognitive Aids in Emergency Airway Equipment Preparation: the Template Airway Trial
A study testing Endotracheal Intubation and Supraglottic Airway in people with Airway Management, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial summary
Comparison of preparation times (in seconds) for emergency airway management (equipment only) with and without a template. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Airway Management
- What is being tested?
- Endotracheal Intubation and Supraglottic Airway
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteGermany
- Study dates
- 15 Apr 2024to 23 Jul 2024
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 18 years and older
- written informed consent
- Qualification as a nurse (ICU or anesthesia)
- employed with University Medical Centre of Johannes Gutenberg University (JGU) Mainz
Who cannot join
- none
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: Evaluation and Comparison of Cognitive Aids in Emergency Airway Equipment Preparation: the Randomized, Controlled Template Airway Trial
Comparison of preparation times (in seconds) for emergency airway management (equipment only) with and without a template.
Read the detailed description
Comparison of time (in seconds) needed to prepare all necessary equipment for one form of emergency airway management with and without a template. Participants will be randomized to "preparation with template (A)" and "preparation without template (B)" and all participants will be measured twice for both arms A and B, however, evaluation will take place on two separate days. Methods of airway management evaluated will be endotracheal intubation, supraglottic airway device and oral fiberoptic intubation, with a total of three measurements per participant per study day and two study days per participant. Participants will be nurses in the intensive care unit and, as a control group, anesthesia nurses will also be evaluated in order to factor in the effects of experience. The study will take place in the usual work environment of participants and with the standard equipment.
- Conditions
- Airway Management
- Being tested
- Endotracheal Intubation, Supraglottic Airway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endotracheal IntubationOther
Preparation of all necessary equipment for endotracheal intubation
Supraglottic AirwayOther
Preparation of all necessary equipment for laryngeal mask
| Study group | Role | What they receive |
|---|---|---|
| Template | Other | Template is provided to prepare necessary equipment for emergency airway management Receives: Other: Endotracheal Intubation; Other: Supraglottic Airway |
| No template | Other | No template is provided to prepare necessary equipment for emergency airway management Receives: Other: Endotracheal Intubation; Other: Supraglottic Airway |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time (in seconds) until completion of preparation of necessary equipment for endotracheal intubation between both groups
Comparison of time (in seconds) until completion of preparation of necessary equipment for endotracheal intubation with and without template
Measured: Defined verbal sign of participant when given task is started and ended
Secondary outcomes (5)
Time (in seconds) until completion of preparation of necessary equipment for supraglottic airway device between both groups
Comparison of time (in seconds) until completion of preparation of necessary equipment for supraglottic airway device with and without template
Measured: Defined verbal sign of participant when given task is started and ended
Number of missing equipment for endotracheal intubation
Comparison of number of missing equipment for endotracheal intubation with and without template
Measured: immediately after completion of intervention
Number of missing equipment for supraglottic airway between groups
Comparison of missing equipment for supraglottic airway with and without template
Measured: immediately after completion of intervention
Number of wrong size/equipment between groups
Comparison of number of wrong size/equipment with and without template
Measured: immediately after completion of intervention
Nasa Task Load Index
Comparison of work load using Nasa Task Load Index questionnaire with and without template
Measured: immediately after completion of all 3 assigned interventions on each study day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start15 Apr 2024
- Primary completion23 Jul 2024
- Study completion23 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ManagementStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- single-center, randomized, controlled simulation study
- Masking
- None (open label)
- Enrolment
- 42 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
- Investigators
- Katharina Epp, M.D., Principal investigator, Employee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06400693
- Sponsor's protocol ID
- 2023-17375
- Other IDs
- 2023
- Acronym
- TemplateAirway
- Status last verified
- Jul 2025
- First submitted
- 14 Apr 2024
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Comparison of Cognitive Aids in Emergency Airway Equipment Preparation: the Randomized, Controlled Template Airway Trial
- ClinicalTrials.gov ID
- NCT06400693
- Acronym / sponsor ID
- TemplateAirway / 2023-17375
- Conditions
- Airway Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 23 Jul 2024 (actual)
- Study completion
- 23 Jul 2024 (actual)
- First posted
- 6 May 2024 (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.
Comparison of preparation times (in seconds) for emergency airway management (equipment only) with and without a template.
Detailed description
Comparison of time (in seconds) needed to prepare all necessary equipment for one form of emergency airway management with and without a template. Participants will be randomized to "preparation with template (A)" and "preparation without template (B)" and all participants will be measured twice for both arms A and B, however, evaluation will take place on two separate days. Methods of airway management evaluated will be endotracheal intubation, supraglottic airway device and oral fiberoptic intubation, with a total of three measurements per participant per study day and two study days per participant. Participants will be nurses in the intensive care unit and, as a control group, anesthesia nurses will also be evaluated in order to factor in the effects of experience. The study will take place in the usual work environment of participants and with the standard equipment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- single-center, randomized, controlled simulation study
| Arm | Type | Receives |
|---|---|---|
| Template | Other | Other: Endotracheal Intubation, Other: Supraglottic AirwayTemplate is provided to prepare necessary equipment for emergency airway management |
| No template | Other | Other: Endotracheal Intubation, Other: Supraglottic AirwayNo template is provided to prepare necessary equipment for emergency airway management |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 18 years and older
- written informed consent
- Qualification as a nurse (ICU or anesthesia)
- employed with University Medical Centre of Johannes Gutenberg University (JGU) Mainz
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Endotracheal IntubationPreparation of all necessary equipment for endotracheal intubation | Other | No template, Template |
| Supraglottic AirwayPreparation of all necessary equipment for laryngeal mask | Other | No template, Template |
Primary outcome
Time (in seconds) until completion of preparation of necessary equipment for endotracheal intubation between both groups
Time frame: Defined verbal sign of participant when given task is started and ended
Comparison of time (in seconds) until completion of preparation of necessary equipment for endotracheal intubation with and without template
5 secondary outcomes
Time (in seconds) until completion of preparation of necessary equipment for supraglottic airway device between both groups
Time frame: Defined verbal sign of participant when given task is started and ended
Number of missing equipment for endotracheal intubation
Time frame: immediately after completion of intervention
Number of missing equipment for supraglottic airway between groups
Time frame: immediately after completion of intervention
Number of wrong size/equipment between groups
Time frame: immediately after completion of intervention
Nasa Task Load Index
Time frame: immediately after completion of all 3 assigned interventions on each study day
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 20 Jul 2025.
- 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.
Katharina Epp, M.D. principal investigator
Employee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endotracheal Intubation and Supraglottic Airway in people with Airway Management, 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 4 inclusion and 1 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 20 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. 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 (in seconds) until completion of preparation of necessary equipment for endotracheal intubation between both groups (time frame: Defined verbal sign of participant when given task is started and ended). 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 20 Jul 2025.