Targeted OXYgen Therapy in Critical Illness

• Status: Completed
• Trial end date: 2020-02-15
• Target enrollment: 0
• Participant gender: All

Summary

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
• Accepts Healthy Volunteers?: No

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

Criteria

Inclusion Criteria:

• Unplanned admission to a critical care unit

• 18 years of age and above (no upper age limit)

• Respiratory failure forms part of the admission diagnosis

• The patient is mechanically ventilated via an endotracheal tube

• The patient is expected to receive mechanical ventilation for > 24 hours

Exclusion Criteria:

• Admission following surgery (elective or unplanned)

• Those patients expected to die within 24 hours of admission to ICU *

• Pregnant females

• Admission post-cardiac arrest

• Admission post trauma (including traumatic brain injury)

• Known sickle cell trait or disease

• Ongoing significant haemorrhage or profound anaemia

• Severe peripheral vascular disease

• Severe pulmonary hypertension

• Other medical conditions where mild hypoxaemia would be contra-indicated ***

• Patients participating in other interventional clinical trials

• As determined by the responsible clinical team ** As determined by the responsible clinical team and /or research team