Prediction of PaO2 Values Using the PRoPERLy II Database

NCT06589427 | Completed

• 1 other identifier: PRoPERLy-II
• Study Type: observational
• Target: 8,000
• Locations: 1 country
• Sites: 1

Brief Summary

Four prospective observational studies of ventilation in critically ill patients were harmonized and pooled.

Conditions

Invasive Ventilation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Mortality.

  Mortality risk based on PaO2/FiO2 or SpO2/FiO2.

  ICU visit, anticipated average 4 days

Secondary Outcomes (2)

• 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.

Study Arms (1)

Invasively ventilated intensive care unit patients.

Critically ill patients receiving invasive ventilation for various reasons, like ARDS, or AHRF.

Other: Invasive ventilation.

Interventions

Invasive ventilation. OTHER

Patients were subjected to invasive ventilation.

Also known as: Respiratory support.

Invasively ventilated intensive care unit patients.

Eligibility Criteria

• Age: 16 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

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

Amsterdam, Netherlands

Location

MeSH Terms

Interventions

Noninvasive Ventilation

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Marcus J Schultz

  Amsterdam UMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: September 19, 2024
• Study Start: January 1, 2024
• Primary Completion: July 26, 2024
• Study Completion: July 26, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Notably, after this initial analysis of PRoPERLy II, the database will be available for additional analysis, till for ever
• Access Criteria: For this, interested investigators will have to provide a detailed analysis plan, containing a testable hypothesis, clearly described endpoints and an analysis plan. After approval, investigators will be provided with a mock database that will allow them to write an analysis script in R. PROVE network investigators will then run the script on the PRoPERLy II database and provide the investigators with the results. Any publication from an additional analysis must follow the rules for publication denoted by the PROVE network

Locations

NL (1)