Cuirass Fitting Study - Time for Mounting and Ventilation
Cuirass
Cuirass Shell Fitting and Time to Visible Ventilation in Healthy Volunteers - an Observational Study.
1 other identifier
observational
60
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 6, 2023
CompletedFirst Posted
Study publicly available on registry
November 18, 2023
CompletedStudy Start
First participant enrolled
November 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2023
CompletedNovember 18, 2023
November 1, 2023
Same day
November 6, 2023
November 13, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
15 minuttes
Other Outcomes (1)
qualitative assessment
15 minuttes
Study Arms (1)
healthy volunteers
participants of the Airway management Course in Copenhagen Denmark 2023
Interventions
We will fit the Cuirass Shell and start Biphasic Cuirass Ventilation on all participants.
Eligibility Criteria
The study population is healthy volunteers, mostly doctors, who participate in a large airway management course i Copenhagen.
You may qualify if:
- participants of the airway course
You may not qualify if:
- Recent surgery in thoracic or abdominal compartments
- participants with pace-maker
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rigshopitalet
Copenhagen, Oesterbro, 2100, Denmark
Related 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.
PMID: 37718095BACKGROUNDKristensen 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.
PMID: 37587006BACKGROUND
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Staff specialist anaesthesiology MD phD
Study Record Dates
First Submitted
November 6, 2023
First Posted
November 18, 2023
Study Start
November 30, 2023
Primary Completion
November 30, 2023
Study Completion
November 30, 2023
Last Updated
November 18, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share