Invasive VentilationPRoPERLy-IINCT06589427
Prediction of PaO2 Values Using the PRoPERLy II Database
An observational study of Invasive Ventilation, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
Four prospective observational studies of ventilation in critically ill patients were harmonized and pooled. Read more about this study
- Who is it for?
- Ages 16 to 99 years
- Conditions the study is for
- Invasive Ventilation
- What is being tested?
- Invasive ventilation.
- How many people
- 8,000 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jan 2024to 26 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Amsterdam
About this study
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)
Four prospective observational studies of ventilation in critically ill patients were harmonized and pooled.
Read the 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.
- Conditions
- Invasive Ventilation
- Being tested
- Invasive ventilation.
- Keywords
- Intensive care, Invasive ventilation, PaO2 prediction, Risk stratification, P/F, S/F
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invasive ventilation.Other
Also called Respiratory support.
Patients were subjected to invasive ventilation.
| Study group | Role | What they receive |
|---|---|---|
| Invasively ventilated intensive care unit patients. | Critically ill patients receiving invasive ventilation for various reasons, like ARDS, or AHRF. Receives: Other: Invasive ventilation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality.
Mortality risk based on PaO2/FiO2 or SpO2/FiO2.
Measured: ICU visit, anticipated average 4 days
Secondary outcomes (2)
Predicted PaO2. SpO 2 /FiO 2 ratios and of predicted PaO 2 /FiO 2 ratios.
PaO2 values predicted from SpO2 values.
Measured: In the first 4 days of invasive ventilation.
Predicted PaO2/FiO2 SpO 2 /FiO 2 ratios and of predicted PaO 2 /FiO 2 ratios.
PaO2/FiO2 predicted from SpO2/FiO2
Measured: In the first 4 days of invasive ventilation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Jan 2024
- Primary completion26 Jul 2024
- Study completion26 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 8,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Marcus J. Schultz, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Marcus J Schultz, Principal investigator, Amsterdam UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06589427
- Sponsor's protocol ID
- PRoPERLy-II
- Acronym
- PRoPERLy-II
- Status last verified
- Sep 2024
- First submitted
- 22 Jul 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06589427
- Acronym / sponsor ID
- PRoPERLy-II / PRoPERLy-II
- Conditions
- Invasive Ventilation
- Keywords
- Intensive care, Invasive ventilation, PaO2 prediction, Risk stratification, P/F, S/F
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,000 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 26 Jul 2024 (actual)
- Study completion
- 26 Jul 2024 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Invasively ventilated intensive care unit patients. | – | Other: Invasive ventilation.Critically ill patients receiving invasive ventilation for various reasons, like ARDS, or AHRF. |
Who may qualify
- Ages
- 16 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Invasive ventilation.Also: Respiratory support.Patients were subjected to invasive ventilation. | Other | Invasively ventilated intensive care unit patients. |
Primary outcome
Mortality.
Time frame: ICU visit, anticipated average 4 days
Mortality risk based on PaO2/FiO2 or SpO2/FiO2.
2 secondary outcomes
Predicted PaO2. SpO 2 /FiO 2 ratios and of predicted PaO 2 /FiO 2 ratios.
Time frame: In the first 4 days of invasive ventilation.
Predicted PaO2/FiO2 SpO 2 /FiO 2 ratios and of predicted PaO 2 /FiO 2 ratios.
Time frame: In the first 4 days of invasive ventilation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Yes. 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
Related trials for Invasive Ventilation
Not yet recruitingObservational study
Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)
Pulmonary Disease, Chronic Obstructive (COPD), Hypercapnia
Not yet recruitingObservational study
Predicting the Need for Invasive Mechanical Ventilation Using Different Risk Scores
High Flow Oxygen Therapy, Non Invasive Ventilation (NIV)
Recruiting
Bedside Spirometry for Acute Lung Injury
Respiratory Insufficiency
Active, not recruitingPhase 3
Comparative Efficacy and Safety of Propofol-Ketamine Combination Versus Propofol Monotherapy in Geriatric Patients Under Invasive Ventilation
The Critically Ill Patient is Requiring Intubation, Septic Shock
Not yet recruiting
Pupillometry vs. BPS (Behavioral Pain Scale) for Analgesia Management in Inpatient Intensive Care Unit Patients on Invasive Mechanical Ventilation
Pupillometry, Behavioral Pain Scale
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcus J Schultz principal investigator
Amsterdam UMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Invasive Ventilation, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality. (time frame: ICU visit, anticipated average 4 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.