Intensive Care patients Mechanical ventilation Oxygenation targets
Conditions
Interventions
The conservative oxygenation arm will be targeted at PaO2 55-80 mmHg (7.3-10.7 kPa) and/or SpO2 91-94% and the conventional oxygenation arm will be targeted at PaO2 between 110-150 mmHg (14.7-20 kPa)
Sponsors
Leiden University Medical Centre
Eligibility
Inclusion criteria
Inclusion criteria: Age ≥ 18 years Admission to an ICU participating in this study Need for intubation and mechanical ventilation An expected mechanical ventilation time of 24 hours or longer Inclusion within 2 hours after start of invasive ventilation in the study ICU or if previously intubated and ventilated within 2 hours after admission to the study ICU
Exclusion criteria
Exclusion criteria: Readmitted to the intensive care unit and prior ICONIC inclusion Invasive ventilation longer than 12 hours directly preceding admission Participation in other interventional trials which could influence ICONIC intervention and/or endpoints Suspected or confirmed pregnancy Decision to withhold life-sustaining treatment at the time of inclusion Acute respiratory distress syndrome (ARDS) with a PaO2/FiO2 ratio less than 150 mmHg Acute decompensation of chronic obstructive pulmonary disease(COPD) and/or chronic hypoxaemia and/or use of home oxygen therapy Underlying disease indication for hyperoxygenation (for example: carbon monoxide intoxication, decompression sickness, gas embolism) Severe anaemia (Hb< 4.0 mmol/l) that is not rapidly reversible (e.g. if blood transfusions are not possible or not allowed for religious reasons) Uncontrollable intracranial hypertension
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause mortality on day 28 after randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| The number of days alive and free from ventilation at day 28 after admission to the intensive care unit (ventilator-free days), ICU-mortality and in-hospital mortality ICU length of stay (LOS), hospital LOS Organ failure (daily) Reintubation rate Cost of hospitalization Ischemic events; myocardial, intestinal, cerebral or peripheral Delirium Blood stream infection and respiratory tract infection Surgical site infection Re-admission within 28 days Long term follow-up: Quality of life at 6 and 12 months after randomisation Patient opinion of research and consent in the emergency setting at 6 months after randomisation | — |
Contacts
Public ContactC.C.A. Grim
Outcome results
None listed