Clinical trial NCT06589427: Prediction of PaO2 Values Using the PRoPERLy II Database
Official title: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Invasive Ventilation
Keywords: Intensive care
Invasive ventilation
PaO2 prediction
Risk stratification
P/F
S/F
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 8000
Sex: ALL
Minimum age (years): 16
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients in the PRoPERLy II database are eligible for this and future analyses. For this first analysus, patients without reported SpO2 values and patients with SpO2 values and PaO2 values not simultaneously recorded are excluded.

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.

Eligibility 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.

Primary outcomes:
measure: Mortality.
timeFrame: ICU visit, anticipated average 4 days
Secondary outcomes:
measure: Predicted PaO2. SpO 2 /FiO 2 ratios and of predicted PaO 2 /FiO 2 ratios.
timeFrame: In the first 4 days of invasive ventilation.
measure: Predicted PaO2/FiO2 SpO 2 /FiO 2 ratios and of predicted PaO 2 /FiO 2 ratios.
timeFrame: In the first 4 days of invasive ventilation.
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study officials:
affiliation: Amsterdam UMC
name: Marcus J Schultz
role: PRINCIPAL_INVESTIGATOR
References: