Invasive ventilation in intensive care Other
Conditions
Interventions
Current interventions as of 20/04/2021:
Patients will be randomly allocated ("randomized"), in a 1:1 ratio, to one of two treatment groups: conservative oxygen therapy (intervention) or usual oxygen t
Sponsors
Intensive Care National Audit & Research Centre (ICNARC)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged =18 years 2. 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) 3. Receiving supplemental oxygen (fractional inspired concentration of oxygen (FiO2) >0.21) at the time of enrolment
Exclusion criteria
Exclusion criteria: 1. Previously randomised into UK-ROX in the last 90 days 2. The clinician considers that one study treatment arm is either indicated or contraindicated. Removed 20/04/2021: A data dictionary will contain relevant examples of conditions where clinicians may exclude patients (at their discretion) because conservative oxygen therapy is either indicated or contraindicated (e.g. chronic lung diseases, receiving hyperbaric oxygen, prior bleomycin exposure, carbon monoxide poisoning). Added 22/02/2021: 3. Currently receiving extracorporeal membrane oxygenation (ECMO)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary clinical outcome: 90-day all-cause mortality, assessed through review of patient medical notes at 90 days post-randomisation and/or data linkage with nationally held death registrations Primary economic outcome: Incremental costs, QALYs and net monetary benefit at 90 days, assessed by combining Health-related Quality of Life (EuroQol EQ-5D-5L questionnaire) data with valued resource use data obtained via a health services questionnaire and data obtained through linkage with national hospital episode statistics, death registrations and the national clinical audit for adult critical care. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. ICU and hospital mortality (censored at 90 days), assessed through review of patient medical notes at the relevant timepoints and/or data linkage with nationally held death registrations 2. Mortality at 60 days and 1 year, assessed through review of patient medical notes at the relevant timepoints and/or data linkage with nationally held death registrations 3. Duration of ICU and acute hospital stay (censored at 90 days), assessed through data linkage with the national clinical audit for adult critical care 4. Days alive and free from organ support at 30 days (an ordinal outcome with death as the worst outcome). Defined as receipt of respiratory, cardiovascular or renal support within critical care according to the Critical Care Minimum Dataset (added 30/10/2024) 5. Health-related quality of life at 90 days, assessed using the EuroQol EQ-5D-5L questionnaire administered to patients at 90 days 6. Resource use and costs at 90 days, assessed by valuing resource use data obtained via a health services questionnaire administered to patients at 90 days and data linkage with national hospital episode statistics and the national clinical audit for adult critical care 7. Estimated lifetime incremental cost-effectiveness, estimated by combining 90-day HrQoL data with valued resource use data obtained via a health services questionnaire at 90 days, data obtained through linkage with national hospital episode statistics, death registrations and the national clinical audit for adult critical care | — |
Countries
United Kingdom
Contacts
Public ContactTasnin Shahid
Outcome results
None listed