Clinical trial NCT06400693: Templates as Cognitive Aids in Emergency Airway Equipment Preparation: the Template Airway Trial
Official title: Evaluation and Comparison of Cognitive Aids in Emergency Airway Equipment Preparation: the Randomized, Controlled Template Airway Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Airway Management
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2024-05-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: single-center, randomized, controlled simulation study
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time (in seconds) until completion of preparation of necessary equipment for endotracheal intubation between both groups
timeFrame: Defined verbal sign of participant when given task is started and ended
Secondary outcomes:
measure: Time (in seconds) until completion of preparation of necessary equipment for supraglottic airway device between both groups
timeFrame: Defined verbal sign of participant when given task is started and ended
measure: Number of missing equipment for endotracheal intubation
timeFrame: immediately after completion of intervention
measure: Number of missing equipment for supraglottic airway between groups
timeFrame: immediately after completion of intervention
measure: Number of wrong size/equipment between groups
timeFrame: immediately after completion of intervention
measure: Nasa Task Load Index
timeFrame: immediately after completion of all 3 assigned interventions on each study day
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Department of Anaesthesiology, University Medical Centre of Johannes Gutenberg University
state: Rhineland-Palatine
Study officials:
affiliation: Employee
name: Katharina Epp, M.D.
role: PRINCIPAL_INVESTIGATOR
References: