Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:01 PM
Study NCT ID:
NCT06136858
Status:
UNKNOWN
Last Update Posted:
2023-11-18
First Post:
2023-11-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cuirass Fitting Study - Time for Mounting and Ventilation
Sponsor:
Rigshospitalet, Denmark
Organization:
Study Overview
Official Title:
Cuirass Shell Fitting and Time to Visible Ventilation in Healthy Volunteers - an Observational Study.
Status:
UNKNOWN
Status Verified Date:
2023-11
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Cuirass
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
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: