Cardiovascular Diseases, Immune System Diseases, Nervous System Diseases, Respiratory Tract Diseases
Conditions
Keywords
Oxygen, Hyperoxia, Intensive care unit, Mortality, Organ dysfunction, Postoperative care
Brief summary
Oxygen administration is a common practice in intensive care units, although concern is growing about oxygen toxicity. The aim of the study is to access whether a rigorous maintenance of a state of normal oxygenation in critically ill patients could obtain better outcomes, such as mortality, infections and organ failures, in comparison to conventional oxygen therapy practice.
Interventions
DRUGOxygen
The lowest inspiratory fraction of oxygen between 21 and 100% in as a short time as possible to maintain SpO2 between 94 and 98% or PaO2 between 70 and 100 mmHg.
Sponsors
University of Modena and Reggio Emilia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* all patients admitted in a post-operative and medical intensive care unit with expected admission of at least three days. Informed consensus as soon as possible
Exclusion criteria
* minority * patient discharged from ICU and successively re-admitted * patient enrolled in other studies * expected survival shorter than 24 hours
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mortality in ICU | 30 days |
Secondary
| Measure | Time frame |
|---|---|
| Rate of organ dysfunctions (respiratory, circulation, renal, liver) | 30 days |
| Rate of nosocomial blood and respiratory infections in intensive care unit and surgery site infections in hospital. | 30 days |
Countries
Italy
Outcome results
None listed