critical care studies summaries

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Protocol v1.7 28/02/2023
Rotherham Principal Investigator: Professor Anil Hormis


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research topic:

Oxygen therapy targets in mechanically ventilated patients

trial groups:

Intervention: Conservative oxygen therapy target SpO2 90% (88-92% permitted)
Control: Usual care (e.g. SpO2 >92% as determined by local clinician

inclusion criteria:

• ​Aged ≥18 years
• Receiving invasive mechanical ventilation in the ICU following an unplanned ICU admission (i.e. not admitted after an elective procedure) OR invasive mechanical ventilation started in the ICU (i.e. the patient was intubated in the ICU)
• Receiving supplemental oxygen (fractional inspired concentration of oxygen (FIO2) >0.21) at the time of enrolment 

exclusion criteria:

• Previously randomised into UK-ROX in the last 90 days
  
• Currently receiving extracorporeal membrane oxygenation (ECMO)
  
• The treating clinician considers that one trial intervention arm is either indicated or contraindicated

randomisation:

Patients eligible for UK-ROX can be randomised straight away without consent required at the time of randomisation.
Sealed envelope website - https://www.sealedenvelope.com/access/
Login email: [email protected]
Password: UK-ROXROTH

what to document:

​This patient has been entered into a research trial:
Trial name: UK-ROX – Evaluating the clinical and cost-effectiveness of a conservative approach to oxygen therapy for invasively ventilated adults in intensive care.
Local study ref. no: 21-03-02
Principal Investigator: Prof Anil Hormis 8334
[Patient Name] met all inclusion and no exclusion for the UK-ROX trial at [Date/Time]. Eligibility confirmed with Dr [XXX]. Randomisation performed by online website by [Staff Name].
[copy and paste the randomisation : date/time/trial ID number/randomisation allocation]
Select as appropriate:
IF CONSERVATIVE: The lowest concentration of oxygen possible should be administered to maintain the patient’s SpO2 at 90 (±2)%.
OR
IF USUAL CARE: Usual oxygen therapy is defined as local practice, as determined by the treating clinician.
 
Consent note: [Patient Name] lacks mental capacity to approach for consent due to ventilation/sedation. Patient was entered into trial prior to consent as per approved trial protocol. Family / consultee will be approached as soon as possible.
For full protocol details of trial can be found in research office DLE91 PGME Corridor or contact 6060.
Any questions please contact Cheryl Graham, Clinical Research Nurse, 6060.