A safety and efficacy trial of the SureflO2™ oxygen mask which incorporates a visual gas flow indicator into a standard oxygen mask.

The aim of this study was to evaluate the clinical application of the SureflO2 oxygen mask in a controlled clinical setting before widespread clinical use. The intended purpose of the device is to monitor the delivery of oxygen to a patient’s airway. The mask is single use. The indicator dynamically confirms gas flow from a distant source into the oxygen face mask. GMDN code 35171.The device was to be used in 250 patients undergoing anaesthetic procedures and its utility and reliability of function observed in the clinical setting. The primary endpoint/outcome was confirmation of reliable function of the device as a visual indicator of oxygen flow as intended in the perioperative clinical setting with identification of any technical or user issues. This trial was performed within the operating theatre suite at a large tertiary teaching hospital in Melbourne (St Vincent's Melbourne). All staff involved in the study participated in a training session conducted by the Principal Investigator/Sponsor/Research Nurse. Staff involved in delivering the intervention were either Consultant Specialist Anaesthetists or accredited Anaesthetic Trainee Doctors. Patients who were considered eligible for the study were invited to participate face to face by an accredited research nurse. Following signing of the Participant Informed Consent Form (PICF), the patient’s eligibility was confirmed and the patient was enrolled in the study. On the day of the procedure participants were treated, in all regards, in the same manner as outside the trial and received standard of care anaesthetic assessment and management. For participants who received regional or local anaesthesia (RA/LA), use of the SureflO2 oxygen mask commenced in the Anaesthetic Room as soon as pre-operative sedation had been administered and continued throughout surgery and the period in the PACU. For participants who received a general anaesthetic (GA), the delivery of supplemental oxygen during surgery is typically achieved via an alternate ‘invasive’ airway device (Laryngeal Mask/Endotracheal Tube) connected to the Anaesthetic machine and therefore the SureflO2 oxygen mask was not utilised during this period. At the conclusion of surgery, for participants who received a GA, the delivery of supplemental oxygen was transitioned to the SureflO2 oxygen mask connected to a portable Oxygen Cylinder (OC) and continued during patient transport from the operating theatre to the PACU. There were 249 patients enrolled over the eleven weeks and one day of the trial. Results of the intervention were populated on a secure on-line survey platform and a full time research nurse was dedicated to the study during its implementation to ensure adherence to protocol and recording of results.