Invasive VentilationPRIMENCT06592937
Harmonized and Pooled Database, Named PRIME.
An observational study of Invasive Ventilation, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
We merged the dataset of three large observational studies of invasive ventilation in critically ill patients. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Invasive Ventilation
- What is being tested?
- Invasive ventilation
- How many people
- 3,270 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 18 to 99 years
- All sexes
- Adult, Older adult
Study population: PROVENT, PROVENT-iMiC and ENIO included various types of patients, receiving ventilation for different reasons. For this first analysis we will select patients receiving invasive ventilation for acute brain injury.
All patients in the PRIME database are eligible for participation in the initial analysis presented here. We will exclude patients receiving ventilation fir another reason than acute brain injury.
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: Potentially Modifiable Ventilation Factors Associated With Outcome in Neurocritical Care vs Non-Neurocritical Care Patients - Rational and Protocol for a Patient-Level Analysis of PRoVENT, PRoVENT-iMiC and ENIO (PRIME)
We merged the dataset of three large observational studies of invasive ventilation in critically ill patients.
Read the detailed description
PRIME contains the individual patient data of 3 large observational studies of ventilation, 'PRactice of VENTilation in critically ill patients without ARDS' (PRoVENT), 'PRactice of VENTilation in critically ill patients in Middle-income Countries' (PRoVENT-iMiC) and 'Extubation strategies and in neuro-intensive care unit patients and associations with outcomes' (ENIO).
- Conditions
- Invasive Ventilation
- Being tested
- Invasive ventilation
- Keywords
- ICU, Invasive ventilation, Respiratory support, Mortality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invasive ventilationOther
Invasive ventilation and respiratory support
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving invasive ventilation | Patients receiving invasive ventilation, included in PRoVENT, PRoVENT-iMiC, and ENIO Receives: Other: Invasive ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU morality
any mortality occurred during ICU stay
Measured: ICU stay, anticipated average 15 days
Secondary outcomes (1)
Mechanical Power
All variables or parameters recorded from the ventilator, when the patient is under mechanical ventilation, to calculate the mechanical power (calculated in Joule/minute)
Measured: During the first 7 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
- 3,270 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, Prof, Principal investigator, Amsterdam UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06592937
- Sponsor's protocol ID
- PRIME-NEU
- Acronym
- PRIME
- 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: Notably, after this initial analysis of PRIME, the database is available for post-hoc analysis.
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
- Potentially Modifiable Ventilation Factors Associated With Outcome in Neurocritical Care vs Non-Neurocritical Care Patients - Rational and Protocol for a Patient-Level Analysis of PRoVENT, PRoVENT-iMiC and ENIO (PRIME)
- ClinicalTrials.gov ID
- NCT06592937
- Acronym / sponsor ID
- PRIME / PRIME-NEU
- Conditions
- Invasive Ventilation
- Keywords
- ICU, Invasive ventilation, Respiratory support, Mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,270 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.
We merged the dataset of three large observational studies of invasive ventilation in critically ill patients.
Detailed description
PRIME contains the individual patient data of 3 large observational studies of ventilation, 'PRactice of VENTilation in critically ill patients without ARDS' (PRoVENT), 'PRactice of VENTilation in critically ill patients in Middle-income Countries' (PRoVENT-iMiC) and 'Extubation strategies and in neuro-intensive care unit patients and associations with outcomes' (ENIO).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients receiving invasive ventilation | – | Other: Invasive ventilationPatients receiving invasive ventilation, included in PRoVENT, PRoVENT-iMiC, and ENIO |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- PROVENT, PROVENT-iMiC and ENIO included various types of patients, receiving ventilation for different reasons. For this first analysis we will select patients receiving invasive ventilation for acute brain injury.
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 ventilationInvasive ventilation and respiratory support | Other | Patients receiving invasive ventilation |
Primary outcome
ICU morality
Time frame: ICU stay, anticipated average 15 days
any mortality occurred during ICU stay
1 secondary outcome
Mechanical Power
Time frame: During the first 7 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. Notably, after this initial analysis of PRIME, the database is available for post-hoc analysis.
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Predicting the Need for Invasive Mechanical Ventilation Using Different Risk Scores
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Recruiting
Bedside Spirometry for Acute Lung Injury
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Active, not recruitingPhase 3
Comparative Efficacy and Safety of Propofol-Ketamine Combination Versus Propofol Monotherapy in Geriatric Patients Under Invasive Ventilation
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Pupillometry vs. BPS (Behavioral Pain Scale) for Analgesia Management in Inpatient Intensive Care Unit Patients on Invasive Mechanical Ventilation
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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, Prof 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?
ICU morality (time frame: ICU stay, anticipated average 15 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.