Safety
ADVERSE EVENTS, EVENT, ADVERSE EVENT
All participants will receive standard care and monitoring by clinical staff. Ventilator settings will be adjusted and additional investigations such as blood gases and chest radiographs will be performed at the discretion of the clinicians. Therefore, there should not be any risk imposed to the intervention group with the addition of the closed-loop automated oxygen delivery system. The system does not mask large increased oxygen requirements between manual observation recordings, as it activates an alarm when there is an increase in the oxygen requirement ≥ 30% from the basal level alerting the clinical team. All serious adverse events will be recorded on a serious adverse event (SAE) form and will be emailed to the sponsor within one working day of the Chief Investigator (CI) becoming aware of the event. When the event is unexpected and thought to be related to the use of the device, this will be reported by the CI/Sponsor to the Ethics and Health Research Authority within fifteen days.