NCT06136858

Cuirass Fitting Study - Time for Mounting and Ventilation

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: —

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.

Conditions

• Airway Disease

Interventions

Type	Name	Description
DEVICE	Cuirass ventilation	We will fit the Cuirass Shell and start Biphasic Cuirass Ventilation on all participants.

Timeline

• Start date: 2023-11-30
• Primary completion: 2023-11-30
• Completion: 2023-11-30
• First posted: 2023-11-18
• Last updated: 2023-11-18

Locations

1 site across 1 country: Denmark