Targeted OXYgen therapy in Critical illness

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 60

Inclusion Criteria

Current inclusion criteria as of 29/11/2018:
1. Unplanned admission to a critical care unit
2. 18 years of age and above (no upper age limit)
3. Respiratory failure forms part of the admission diagnosis
4. The patient is mechanically ventilated via an endotracheal tube
5. The patient is expected to receive mechanical ventilation for > 24 hours
N.B. In the TOXYC trial, the trigger for inclusion is at the point of intubation and not at admission. E.g. A subject that is admitted but not intubated is not eligible but a subject who deteriorates to the point of requiring intubation and is then intubated then becomes eligible. Once a subject is intubated, site has 24 hours to gain the appropriate consent, enrol and randomise the subject, should site chose to

Previous inclusion criteria:
1. Unplanned admission to a critical care unit
2. 18 years of age and above (no upper age limit)
3. Respiratory failure forms part of the admission diagnosis
4. The patient is mechanically ventilated via an endotracheal tube
5. The patient is expected to receive mechanical ventilation for > 72 hours
N.B. In the TOXYC trial, the trigger for inclusion is at the point of intubation and not at admission. E.g. A subject that is admitted but not intubated is not eligible but a subject who deteriorates to the point of requiring intubation and is then intubated then becomes eligible. Once a subject is intubated, site has 24 hours to gain the appropriate consent, enrol and randomise the subject, should site chose to

Exclusion Criteria

1. Admission following surgery (elective or unplanned)
2. Those patients expected to die within 24 hours of admission to ICU *
3. Pregnant females
4. Admission post-cardiac arrest
5. Patients with chronic lung disease known (or highly suspected) to have baseline oxygen saturations in the range of the intervention arm (i.e. 88-92%)
6. Admission post trauma (including traumatic brain injury)
7. Known sickle cell trait or disease
8. Ongoing significant haemorrhage or profound anaemia
9. Severe peripheral vascular disease
10. Severe pulmonary hypertension
11. Other medical conditions where mild hypoxaemia would be contraindicated **
12. 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility, assessed by:<br>1. Ability to recruit patients at the two sites (recruitment rate), evaluated by monitoring patient screening and subsequent agreement to participate, along with any withdrawal of consent during or after the study<br>2. Support for the trial from involved clinicians and healthcare workers<br>3. Rate of withdrawal from both the intervention and control groups<br>4. Reasons for any withdrawal from the study, assessed by the trial management group at the end of the study to then evaluate whether the protocols were suitable<br>5. Implementation of targeted oxygen, evaluated by analysing adherence to oxygenation goals and completion of intervention without protocol violations

Secondary Outcome Measures

Name	Time	Method

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