Cuirass Fitting Study - Time for Mounting and Ventilation (Cuirass)

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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Airway Disease
• Intervention / Treatment: Device: Cuirass 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.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

Study Locations

• Denmark
  • Oesterbro
    • Copenhagen, Oesterbro, Denmark, 2100
      • Rigshopitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

Inclusion Criteria:

• participants of the airway course

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
healthy volunteers; participants of the Airway management Course in Copenhagen Denmark 2023	Device: Cuirass ventilation; We will fit the Cuirass Shell and start Biphasic Cuirass Ventilation on all participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): November 30, 2023
• Primary Completion (Estimated): November 30, 2023
• Study Completion (Estimated): November 30, 2023

Study Registration Dates

• First Submitted: November 6, 2023
• First Submitted That Met QC Criteria: November 13, 2023
• First Posted (Estimated): November 17, 2023

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Seizures
• Other Study ID Numbers: The Cuirass Fitting Trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No