Prediction of PaO2 from SpO2 Values in Critically Ill Invasively Ventilated Patients - Rationale and Protocol for a Patient-level Analysis of ERICC, LUNG SAFE, PRoVENT and PRoVENT-iMiC (PRoPERLy II)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 8,000
- Locations
- 1
- Primary Endpoint
- Mortality.
Study Overview
Brief Summary
Four prospective observational studies of ventilation in critically ill patients were harmonized and pooled.
Detailed Description
The individual data from four observational studies ('Epidemiology of Respiratory Insufficiency in Critical Care study' [ERICC], the 'Large Observational Study to Understand the Global Impact of Severe Acute Respiratory Failure' [LUNG SAFE], 'PRactice of VENTilation in critically ill patients without ARDS' [PRoVENT], 'PRactice of VENTilation in critically ill patients in Middle-income Countries' [PRoVENT-iMiC]) were harmonized and pooled into a database named 'PRoPERLy II'. This database will be used to address various issues in diverse patient categories.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 16 Years to 99 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Mortality.
Time Frame: ICU visit, anticipated average 4 days
Mortality risk based on PaO2/FiO2 or SpO2/FiO2.
Secondary Outcomes
- Predicted PaO2. SpO 2 /FiO 2 ratios and of predicted PaO 2 /FiO 2 ratios.(In the first 4 days of invasive ventilation.)
- Predicted PaO2/FiO2 SpO 2 /FiO 2 ratios and of predicted PaO 2 /FiO 2 ratios.(In the first 4 days of invasive ventilation.)
Investigators
Prof. Dr. Marcus J. Schultz
Prof. Dr
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)