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Completed

NCT Number: NCT07076511

A Novel Intuitive Airway Trolley for Quick Decision-making in Simulated Unexpected Difficult Airway Situations: Evaluation and Comparison to the Existing Airway Trolley

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:

1. 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? 2. how many deviations from the algorithm "unexpected difficult airway" are documented for each trolley (novel vs existing)? 3. are there differences in the provider experience between both trolleys

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Key information

Conditions

Airway Morbidity Human Factors Intubation; Difficult or Failed Team Efficacy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anaesthesiology, University Medical Centre of Johannes Gutenberg University

Mainz, Rhineland-Palatine, 55131, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • anaesthesiological 2nd and 3rd year residents at University Medical Centre Mainz
  • anaesthesiological attendings at University Medical Centre Mainz
  • informed written consent

Treatment and study plan

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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 until the decision to prepare (but not directly execute) eFONA (in sec)

  2. Time to establish successful oxygenation (in seconds)

    Time frame: Maximum time to solve scenario: 10 minutes

    Time to establish successful oxygenation (defined as successfully conducting eFONA and performing ventilation) in seconds

  3. number of departures from difficult airway algorithm

    Time frame: Through the course of the scenario (maximum time for completion 10 minutes)

    The number of times during the scenario that the treatment is not concordant with the difficult airway algorithm

  4. Gender differences in the time until eFONA

    Time frame: Maximum time to solve the scenario: 10 minutes

    Gender differences in the time until eFONA is performed

  5. Gender differences in number of departures from difficult airway algorithm

    Time frame: Maximum time to solve the scenario: 10 minutes

    Gender differences in number of departures from difficult airway algorithm

  6. subjective work load evaluation

    Time frame: To be filled out after completing the scenario (time given: 3 minutes)

    evaluating the work load using NASA task load scale (NASA-TLX) questionnaire (nominal scale from very low to very high)

  7. number of unnecessary drawer opening

    Time frame: Through the course of the scenario (maximum time for completion 10 minutes)

    The number of times during the scenario that drawers are opened without retrieving any equipment

  8. subjective operator experience

    Time frame: To be filled out after completing the scenario (time given: 3 minutes)

    Experience of the operator using an ordinal scale (1-7)

Sponsors and collaborators

Lead sponsor

Johannes Gutenberg University Mainz

Other

Registry information

Official study 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

Acronym: Airway-to-Go

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 22, 2025
Registry last updated
Jul 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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