Study Title: A randomised controlled trial of targeted oxygen therapy in mechanically ventilated critically ill patients. (A feasibility study)
Short Title: TOXYC
The administration of high concentrations of oxygen to patients have proved to be harmful in some settings, especially in patients already suffering from damage to their lungs. Patients who require assistance to their breathing with an artificial ventilator due to disease of their lungs are frequently given high concentrations of oxygen to maintain a normal level of oxygen in their blood. It is therefore essential to strike a balance between the benefits and harms of having a normal blood oxygen level.
We intend to recruit critically ill patients requiring artificial ventilation into a randomised controlled trial to assess the feasibility of conducting a trial that determines blood oxygen levels. Patients will be allocated to either a normal or lower than normal blood oxygen group. Doctors and nurses looking after patients in the trial will adjust the amount of oxygen they administer to ensure that the patient's blood oxygen level remains in the allocated target range. Blood oxygen level will be monitored with a standard non-invasive monitor (a pulse oximeter). A total of 60 patients will be recruited at two different hospitals.
Feasibility will be assessed by the ease of recruiting complex critically ill patients into a trial of this nature, and the ability of clinical teams to deliver the intervention. A secondary purpose of the study is to look at specific biological markers in blood samples collected from participants, to see if they are associated with clinical outcomes.
The information from this study will be used to create a large multi-centre trial to fully evaluate targeted oxygen therapy in critically ill patients.
Sponsor: University College London (UCL)
Funders: The National Institute for Health and Research (Research for Patient Benefit) and The Royal Free Charity