Templates as Cognitive Aids in Emergency Airway Equipment Preparation: the Template Airway Trial (TemplateAirway)

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.

Study Overview

• Status: Completed
• Conditions: Airway Management
• Intervention / Treatment: Other: Endotracheal Intubation; Other: Supraglottic Airway

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 Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Rhineland-Palatine
    • Mainz, Rhineland-Palatine, Germany, 55131
      • Department of Anaesthesiology, University Medical Centre of Johannes Gutenberg University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Template; Template is provided to prepare necessary equipment for emergency airway management	Other: Endotracheal Intubation; Preparation of all necessary equipment for endotracheal intubation; Other: Supraglottic Airway; Preparation of all necessary equipment for laryngeal mask
Other: No template; No template is provided to prepare necessary equipment for emergency airway management	Other: Endotracheal Intubation; Preparation of all necessary equipment for endotracheal intubation; Other: Supraglottic Airway; Preparation of all necessary equipment for laryngeal mask

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Defined verbal sign of participant when given task is started and ended

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	immediately after completion of intervention
Number of wrong size/equipment between groups	Comparison of number of wrong size/equipment with and without template	immediately after completion of intervention
Nasa Task Load Index	Comparison of work load using Nasa Task Load Index questionnaire with and without template	immediately after completion of all 3 assigned interventions on each study day

Collaborators and Investigators

• Sponsor: Johannes Gutenberg University Mainz
• Investigators: Principal Investigator: Katharina Epp, M.D., Employee

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2024
• Primary Completion (Actual): July 23, 2024
• Study Completion (Actual): July 23, 2024

Study Registration Dates

• First Submitted: April 14, 2024
• First Submitted That Met QC Criteria: May 2, 2024
• First Posted (Actual): May 6, 2024

Study Record Updates

• Last Update Posted (Actual): July 20, 2025
• Last Update Submitted That Met QC Criteria: July 16, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: 2023-17375

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No