Clinical trial NCT06136858: Cuirass Fitting Study - Time for Mounting and Ventilation
Official title: Cuirass Shell Fitting and Time to Visible Ventilation in Healthy Volunteers - an Observational Study.
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Airway Disease
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is healthy volunteers, mostly doctors, who participate in a large airway management course i Copenhagen.

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.

Eligibility criteria: Inclusion Criteria:

* participants of the airway course

Exclusion Criteria:

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

Primary outcomes:
measure: 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.
timeFrame: 15 minuttes
Secondary outcomes:
measure: 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
timeFrame: 15 minuttes
Other outcomes:
measure: qualitative assessment
timeFrame: 15 minuttes
Locations:
city: Copenhagen
country: Denmark
facility: Rigshopitalet
state: Oesterbro
Study officials:
References:
citation: Kristensen MS, Hesselfeldt R, Schmidt JF. Improvements in cuirass ventilation for airway surgery: origins in Copenhagen on the 70th anniversary of the first intensive care unit. Br J Anaesth. 2023 Oct;131(4):644-648. doi: 10.1016/j.bja.2023.07.021. Epub 2023 Sep 4.
citation: Kristensen MS, Hesselfeldt R, Schmidt JF. Modern cuirass ventilation for airway surgery: unlimited access to the larynx and trachea in anaesthetised patients. Br J Anaesth. 2023 Oct;131(4):e106-e109. doi: 10.1016/j.bja.2023.07.010. Epub 2023 Aug 14. No abstract available.