Xenon neuroprotection in hyperbaric or pre-hospital setting via novel modular ventilation and anaesthesia system

Mechanical ventilation (MV) is an essential form of organ support that underpins survival in severe ABI, in which respiratory failure or loss of airway reflexes are common1,2,3 and where sedation to reduce brain metabolism and control of ventilation/position to manage intracranial pressure is needed1. ABI patients supported by MV are transported frequently4,5, often when they are most vulnerable for imaging/surgery, swapping between a multitude of different devices or manual ventilation. Poor ventilation control6 and adverse events are common7, death occurs8,9 and equipment issues are often causal7,8,9. There is an unmet need for a single MV device, used across the hospital, to significantly reduce risks associated with MV transfer, improve hospital efficiency and provide a single high-resolution data source for our most unwell and complex patients. Fig1. Current Multi-Device Pathway PenMed have developed a portable Ventilator Module (VM) for transport/ICU/ward that reversibly docks with an anaesthesia module to provide volatile anaesthesia in theatre. This system provides high-flow oxygen, non-invasive and invasive ventilation and efficient circle-system anaesthesia without disconnecting the patient gas connection. The device stays with the patient, everywhere they go, while they require ventilation/oxygen support. PenMed have developed advanced prototypes and achieved safety and performance equivalent to or better than state of the art devices. We expect to start Clinical Investigations in January 2026. Fig2 PenMed Ventilator Module Fig3. PenMed Pathway Fig4. Early Formative Testing of User Interfaces/handling in NHS By working across the trauma pathway, this device is ideal for the management of severe ABI requiring MV but additionally, the novel, patented, gas circuit allows circle system recirculation in a transport ventilator form-factor. This means that it can: Work at ultra-low flow of oxygen (200ml/min) rather than conventional ventilators (>5L/min) Manage Xenon anaesthesia Do the above while in hyperbaric conditions or in a pre-hospital setting Xenon is a potent neuroprotective anaesthetic agent in pre-clinical models of ABI10, including blast trauma11 and is being evaluated in neonatal encephalopathy12 and cardiac arrest13 but requires circle system operation due to its limited availability and is ideally administered soon after injury14. Although exerting neuroprotective effects at atmospheric pressure, full anaesthesia and optimal neuroprotection can be given at mildly hyperbaric conditions15. There are a number of hyperbaric chambers in the UK and portable versions are used widely by the military16. Current ventilators/anaesthesia machines are not capable of using Xenon and an old, no-longer produced anaesthesia machine was used for recent phase II studies13, limiting its potential use. PenMed s system can improve care of the ABI patient, but also offers the potential to administer Xenon through a new conventional state-of-the-art device in the early stages of injury when it is most effective. PPIE Experience: PenMed has conducted PPIE with the University of Exeter and a group of patients with lived experience of ICU. Patients identified three key themes for consideration: Patient access to device safety data and importance of clinical record integrity Patients were happy for AI/ML learning but wanted to access understanding Patients wanted to be able to consent for data sharing/use by AI/ML