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

NCT07076511 | Completed

• 1 other identifier: Airway-to-Go
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Airway Morbidity; Team Efficacy; Intubation; Difficult or Failed; Human Factors

Keywords

Difficult Airway Trolley; Human factors; Team performance; visual aids

Outcome Measures

Primary Outcomes (1)

• 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)

  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 (in seconds) when decision to prepare eFONA is verbalized (maximum time to solve scenario 10 minutes)

• Time to establish successful oxygenation (in seconds)

  Maximum time to solve scenario: 10 minutes

• number of departures from difficult airway algorithm

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

• Gender differences in the time until eFONA

  Maximum time to solve the scenario: 10 minutes

• Gender differences in number of departures from difficult airway algorithm

  Maximum time to solve the scenario: 10 minutes

Study Arms (2)

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

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

Other: Scenario "unexpected difficult airway"

Interventions

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.

Existing Airway Trolley; Novel Airway Trolley

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Johannes Gutenberg University Mainz: lead

Study Sites (1)

Department of Anaesthesiology, University Medical Centre of Johannes Gutenberg University

Mainz, Rhineland-Palatine, 55131, Germany

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: randomized, controlled, single-blinded simulation study

Study Record Dates

• First Submitted: July 16, 2023
• First Posted: July 22, 2025
• Study Start: July 1, 2025
• Primary Completion: July 11, 2025
• Study Completion: July 11, 2025
• Last Updated: July 22, 2025

Record last verified: 2025-07

Locations

DE (1)