Prediction of PaO2 Values Using the PRoPERLy II Database

Completed

• Conditions: Invasive Ventilation
• Interventions: Other: Invasive ventilation.

• Registration Number: NCT06589427
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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 Timeline

• Study Start: 2024-01-01
• Study First Submitted: 2024-07-22
• Primary Completion: 2024-07-26
• Study Completion: 2024-07-26
• Status Verified: 2024-09
• Study First Submitted QC: 2024-09-06
• Last Update Submitted: 2024-09-06
• Study First Posted: 2024-09-10
• Last Update Posted: 2024-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Invasively ventilated intensive care unit patients.	Invasive ventilation.	Critically ill patients receiving invasive ventilation for various reasons, like ARDS, or AHRF.

Primary Outcome Measures

Name	Time	Method
Mortality.	ICU visit, anticipated average 4 days	Mortality risk based on PaO2/FiO2 or SpO2/FiO2.

Secondary Outcome Measures

Name	Time	Method
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.
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

Trial Locations

Locations (1)

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA); 🇳🇱 Amsterdam, Netherlands