Critically ill patients because of chronic or acute respiratory, circulatory, neurologic, infective, metabolic, renal or hepatic pathologies. MedDRA version: 9.1 Level: SOC Classification code 10038738 MedDRA version: 9.1 Level: SOC Classification code 10047065 MedDRA version: 9.1 Level: SOC Classification code 10019805 MedDRA version: 9.1 Level: SOC Classification code 10021881
Conditions
Interventions
Pharmaceutical Form: Inhalation gas
INN or Proposed INN: Oxygen
Concentration unit: l litre(s)
Concentration type: equal
Sponsors
U.O. Terapia intensiva
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All patients admitted to the intensive care unit of Policlinico di Modena in the study period from 01/12/2009 to 30/11/2011 with an expected lenght of stay of at least 3 days. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Patients age lower than 18 - Patients discharged from intensive care unit and than re-admitted during study period - Patients partecipating to other prospective studies - Expected survival < 24 hours
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Main objective of the study is the assessment that a rigorous normoxia maintenance, avoiding hypoxia and hyperoxia states, can reduce intensice care unit mortality.;Secondary Objective: Secondary objectives are: - reduction of new onset of organ failures (respiratory, circulatory, renal, hepatic) in intensive care unit - reduction of new onset of infections in intensive care unit (pneumonia, blood) or in hospital (surgical site).;Primary end point(s): Mortality reduction in intensive care unit. | — |
Countries
Italy
Outcome results
None listed