Cuirass Fitting Study - Time for Mounting and Ventilation

Study Overview
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Brief Summary
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Non-invasive biphasic cuirass ventilation (BCV) has recently been described for ENT surgery (ref 1-2). The clinical experience is however still sparse and further study is required. The purpose of the study is to descibe 1) mounting time and fitting of the cuirass shell on voluntary participants and 2) time to visible ventilation

Detailed Description
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The purpose of this study is to evaluate the the fitting of the Cuirass shell on healthy volunteers. Even though there is growing knowledge of Cuirass ventilation in anaesthesia, (ref. 1-2) there is sparse experiences with the time required for fitting the Cuirass shell and the time to start of ventilation. This knowledge is paramount before even discussing the potential use of Cuirass ventilation in acute settings in the future. In addition to the invitation to the Copenhagen Airway Management course in Copenhagen Denmark on 30th of November 2023, all participants have been invited an has accepted to participate in the study. In total 60 to 65 participants will all have the Cuirass shell fitted and will be awake ventilated with Biphasic Cuirass Ventilation. All participants have given consent to being video filmed. The study will register the time it takes to fit the Cuirass shell and the time before visible ventilation is obtained. All participants will be in their habitual state i.e..no sedation is required since the product was originally designed for home use in awake patients.

Official Title
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Cuirass Shell Fitting and Time to Visible Ventilation in Healthy Volunteers - an Observational Study.

Conditions
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Airway Disease

Intervention / Treatment
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* Device: Cuirass ventilation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: participants of the airway course Exclusion Criteria: Recent surgery in thoracic or abdominal compartments participants with pace-maker
Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| healthy volunteers<br>participants of the Airway management Course in Copenhagen Denmark 2023 | Device: Cuirass ventilation<br>* We will fit the Cuirass Shell and start Biphasic Cuirass Ventilation on all participants.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary end point of the study is to evaluate the number of participants who are fitted with the Cuirass shell and have visible ventilation in a two liters breathing bag within three minutes. | Timing of the above | 15 minuttes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean time for fitting of the cuirass shell and start of visible ventilation and fraction of participants who can be ventilated within one minute and within two minuttes | timing of the above | 15 minuttes |