Cuirass Fitting Study - Time for Mounting and Ventilation
- Conditions
- Airway Disease
- Interventions
- Device: Cuirass ventilation
- Registration Number
- NCT06136858
- Lead Sponsor
- Rigshospitalet, Denmark
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 60
- participants of the airway course
- Recent surgery in thoracic or abdominal compartments
- participants with pace-maker
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description healthy volunteers Cuirass ventilation participants of the Airway management Course in Copenhagen Denmark 2023
- Primary Outcome Measures
Name Time Method 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. 15 minuttes Timing of the above
- Secondary Outcome Measures
Name Time Method 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 15 minuttes timing of the above
Trial Locations
- Locations (1)
Rigshopitalet
🇩🇰Copenhagen, Oesterbro, Denmark