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

Airway Management Clinical Trial

— TemplateAirway  

Official title:

Evaluation and Comparison of Cognitive Aids in Emergency Airway Equipment Preparation: the Randomized, Controlled Template Airway Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06400693
• Other study ID #: 2023-17375
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2024
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2024
• Source: Johannes Gutenberg University Mainz
• Contact: Katharina Epp, M.D.
• Phone: 00491624077185
• Email: kathaepp[@]uni-mainz.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Comparison of preparation times (in seconds) for emergency airway management (equipment only) with and without a template.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Airway Management
• Emergencies

Intervention

Other:
• Endotracheal Intubation
Preparation of all necessary equipment for endotracheal intubation
• Supraglottic Airway
Preparation of all necessary equipment for laryngeal mask

Locations

Country	Name	City	State
Germany	Department of Anaesthesiology, University Medical Centre of Johannes Gutenberg University	Mainz	Rhineland-Palatine

Sponsors (1)

Lead Sponsor	Collaborator
Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Number of wrong size/equipment between groups	Comparison of number of wrong size/equipment with and without template	immediately after completion of intervention
Secondary	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