None listed
Conditions
Brief summary
We herein propose a simple, achievable and safe method of assisting ventilation using a high throughput device, which can be operated without specific skills in ventilator management. The device is a modernised version of the Both Respirator created in 1939. A Modern commercial version has been FDA approved in the United States by Hayek Medical, but currently lacks Australian distribution. As advertised by Hayek Medical, a cuirass ventilator does not require skilled medical professionals. Our simplified device has also been designed to not require a skilled medical professional. Moreso, this device is specifically designed with simplified parts so it can be built quickly and easily in regional areas.
Interventions
This study is an unblinded trial of a cuirass based negative pressure ventilator.
The device consists of a plastic casing (cuirass) placed over the thorax with negative pressure of -200cmH2O applied by a household vacuum cleaner.The negative pressure in the cuirass facilitates inspiration. The device cycles back to atmospheric pressure allowing expiration.
Following confirmation of fit by the research team, application of ANZCA standard monitoring (Australian and New Zealand College of Anaesthe
This study is an unblinded trial of a cuirass based negative pressure ventilator. The device consists of a plastic casing (cuirass) placed over the thorax with negative pressure of -200cmH2O applied by a household vacuum cleaner.The negative pressure in the cuirass facilitates inspiration. The device cycles back to atmospheric pressure allowing expiration. Following confirmation of fit by the research team, application of ANZCA standard monitoring (Australian and New Zealand College of Anaesthetists, 2017) and trial of the device in an awake volunteer, the study will use sedation to simulate an unwell patient. Baseline data before intervention will include AVPU level of consciousness, HR, SpO2 and Vt on room air, then HR and SpO2 on 4L/min via Hudson mask. The patient will be ventilated using the device with supplemental oxygen via Hudson face mask at 4L/min for one hour. Tidal volumes will be recorded every 15 minutes. The Hudson mask will be removed and a face mask connected to a GE Anaesthetic Machine running FiO2 at 30%, 4L/min will be used to record Vt for 3 consecutive breaths. Sedation will be provided by an accredited Consultant Anaesthetist and targeted to maintain an AVPU score of ‘V’, that is, rousable to command. The level of sedation will be targeted to not require direct airway intervention. Sedation will be provided using propofol and Total Intravenous Anaesthesia (TIVA) using the Marsh algorithm. An initial bolus of Lignocaine will be included with the propofol to minimise patient discomfort as per accepted practice. An anaesthetic record will be maintained as per ANZCA Guidelines (Australian and New Zealand College of Anaesthetists, 2019). The trial will be conducted in an operating theatre environment with full resuscitation capabilities including trained assistance and support staff.
Sponsors
Dr Michael Soares
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
35 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1 healthy volunteer, of average age and size.
Exclusion criteria
Pre-exisiting medical illness. History of adverse reaction to anaesthetic agent.
Outcome results
None listed