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NCT06136858 Clinical Trial

Cuirass Fitting Study - Time for Mounting and Ventilation

Airway Disease Clinical Trial

— Cuirass  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT06136858
Other study ID # The Cuirass Fitting Trial
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date November 30, 2023
Est. completion date November 30, 2023

Study information
Verified date November 2023
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

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 information / eligibility
Status Enrolling by invitation
Enrollment 60
Est. completion date November 30, 2023
Est. primary completion date November 30, 2023
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - participants of the airway course Exclusion Criteria: - Recent surgery in thoracic or abdominal compartments - participants with pace-maker

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Cuirass ventilation
We will fit the Cuirass Shell and start Biphasic Cuirass Ventilation on all participants.

Locations
Country Name City State
Denmark Rigshopitalet Copenhagen Oesterbro

Sponsors (1)
Lead Sponsor Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

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. — View 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Other qualitative assessment During 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 15 minuttes
Primary 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. Timing of the above 15 minuttes
Secondary 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 timing of the above 15 minuttes
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