A First-in-Human Feasibility Study of the Lycovent Portable Mechanical Ventilator

1. Brief Description of the Ventilator Intervention This study assesses the Lycovent portable ventilator for short-term use during surgery. Each patient is initially stabilized on the conventional hospital ventilator for approximately 15 minutes. Once they have reached stable anaesthesia and ventilation parameters, the patient is switched to the Lycovent ventilator for approximately 30 minutes. After that, they are returned to the conventional ventilator for the remainder of the anaesthetic. Automatic vs. Manual Operation The Lycovent ventilator is primarily automatic once key parameters (tidal volume, pressure limits, respiratory rate, etc.) are set. An anaesthetist will make any required adjustments. Frequency/Duration of Intervention Each participant uses the Lycovent for about 30 minutes in the middle of their procedure. This is framed by a baseline period on the conventional ventilator (15 minutes to establish stability) and a return to the conventional ventilator for the remainder of the surgery. Monitoring Adherence Adherence is monitored via standard anaesthetic record keeping (e.g., documenting ventilator changes and vital signs) and any available ventilator-generated data logs (if applicable). This ensures the correct usage interval and settings are recorded. 2. Crossover Design & Wash-Out Period This is a crossover trial in that each participant is exposed to both the conventional hospital ventilator and the Lycovent within the same surgical procedure. However, all participants follow the same sequence: Conventional ventilator for 15 minutes (baseline/stabilization) Switch to Lycovent for 30 minutes Switch back to conventional ventilator for the rest of the anaesthetic A traditional “wash-out period” is not applicable in the usual pharmacological sense because these are mechanical ventilation devices rather than drugs; there is no expected carry-over effect. The short interval required to move from one ventilator to the other effectively acts as the “wash out.” 3. Non-Randomised Allocation Method All participants follow the same, fixed sequence (i.e., conventional then Lycovent then conventional). There is no randomisation or alternation in the order of device use. Consequently, this is a non-randomised crossover trial.