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Prediction of PaO2 Values Using the PRoPERLy II Database

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)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06589427
Acronym
PRoPERLy-II
Enrollment
8000
Registered
2024-09-19
Start date
2024-01-01
Completion date
2024-07-26
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Invasive Ventilation

Keywords

Intensive care, Invasive ventilation, PaO2 prediction, Risk stratification, P/F, S/F

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.

Interventions

OTHERInvasive ventilation.

Patients were subjected to invasive ventilation.

Sponsors

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

ERICC included patients aged 18 years or older that received ventilatory support for at least 24 hours during the first 48 hours of ICU admission at the participating ICUs. ERICC excluded patients with a tracheostomy, patients admitted for routine uncomplicated postoperative care, readmissions and patients with a terminal condition. ERICC enrolled patients during 2-months period. LUNG SAFE included patients aged 16 years or older that received invasive or noninvasive ventilation. LUNG SAFE excluded patients without informed consent. LUNG SAFE enrolled patients during a 4-week period in the winter months. PRoVENT included patients aged 18 years or older that received invasive ventilation. PRoVENT excluded patients in whom ventilation was started before the study recruitment week, patients receiving only noninvasive ventilation, and patients that were transferred to the ICU from another hospital under ventilation. PRoVENT enrolled patients during 4-week period. PRoVENT-iMiC included patients aged 18 years or older that started with invasive ventilation. They excluded patients that received only noninvasive ventilation, patients whose invasive ventilation started before the inclusion phase of the study, and patients transferred from another hospital while under ventilation. PRoVENT-iMiC enrolled patients during 4-week period.

Design outcomes

Primary

MeasureTime frameDescription
Mortality.ICU visit, anticipated average 4 daysMortality risk based on PaO2/FiO2 or SpO2/FiO2.

Secondary

MeasureTime frameDescription
Predicted PaO2/FiO2 SpO 2 /FiO 2 ratios and of predicted PaO 2 /FiO 2 ratios.In the first 4 days of invasive ventilation.PaO2/FiO2 predicted from SpO2/FiO2
Predicted PaO2. SpO 2 /FiO 2 ratios and of predicted PaO 2 /FiO 2 ratios.In the first 4 days of invasive ventilation.PaO2 values predicted from SpO2 values.

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026