The investigators propose to conduct a feasibility, multi-centre, randomised controlled trial
of targeted oxygen therapy in adult critically ill patients receiving mechanical ventilation
via an endotracheal tube as part of their treatment for respiratory failure. Participants
will be allocated to either a normal blood oxygen target group or a lower than normal blood
oxygen target group. The primary purpose of the study will be to assess the feasibility of
recruiting complex patients who lack capacity into a clinical trial in which oxygenation is
being assessed, and that the clinicians responsible for these patients are able to deliver
the intervention effectively. The safety of using a lower than normal blood oxygen target
will also be assessed and blood samples taken for subsequent investigation of the biological
mechanisms underlying the observed changes.
Participants will be randomised (1:1) into either an intervention or control group. The
intervention in this trial is tightly controlled administration of oxygen to patients to
achieve a haemoglobin oxygen saturation (SpO2) of 88-92%. The control group will also have
tightly controlled oxygen administration, but to achieve an SpO2 of 96% or above. The target
for the control group represents a normal SpO2, whilst that in the intervention group is
lower than what is considered to be normal. It should be noted that although lower than
normal, this SpO2 is close to what the general public experience when travelling by
pressurised aircraft as the fractional inspired oxygen concentration in that situation is
only 0.15-0.17 (15-17%).
The controlled oxygen administration would commence as soon as possible after admission to
the critical care unit and end following removal of the participant's artificial breathing
tube. The researchers and clinical team cannot be blinded to treatment allocation, due to the
nature of the intervention. Those analysing the data will be blinded to the intervention.
Phase:
N/A
Details
Lead Sponsor:
University College, London
Collaborators:
National Institute for Health Research, United Kingdom Royal Free Charity Royal Free Hospital NHS Foundation Trust University Hospital Southampton NHS Foundation Trust