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Cuirass Fitting Study - Time for Mounting and Ventilation

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06136858
Acronym
Cuirass
Enrollment
60
Registered
2023-11-18
Start date
2023-11-30
Completion date
2023-11-30
Last updated
2023-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Airway Disease

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.

Interventions

DEVICECuirass ventilation

We will fit the Cuirass Shell and start Biphasic Cuirass Ventilation on all participants.

Sponsors

Rigshospitalet, Denmark
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL

Inclusion criteria

* participants of the airway course

Exclusion criteria

* Recent surgery in thoracic or abdominal compartments * participants with pace-maker

Design outcomes

Primary

MeasureTime frameDescription
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 minuttesTiming of the above

Secondary

MeasureTime frameDescription
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 minuttes15 minuttestiming of the above

Other

MeasureTime frameDescription
qualitative assessment15 minuttesDuring Cuirass ventilation did you experience discomfort on a scale from 1 to 10, Pain on a scale from 1 to10 And if Cuirass ventilation was the main driver of the partipants ventilation

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026