ICU AdmissionPrognostICateNCT06289075
PrognostICate- Study:Prognostication of ICU- and Ventilator- Days Over the Next Years Until 2040
An observational study of ICU Admission, run by University Hospital of Cologne at 1 site in Germany.
Trial summary
The Objective of this retrospective multicenter- study is to forecast Intensive Care Unit (ICU) length of stay (ICULOS) and length of mechanical ventilation (LOMV) in ICU patients of different groups (regarding gender, age group, medical vs surgical admission) worldwide for the next years up to the year of 2040 using… Read more about this study
- Who is it for?
- Ages 1 day to 120 years
- Conditions the study is for
- ICU Admission
- What is being tested?
- Intensive Care Unit (ICU) treatment
- How many people
- 10,000,000 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2024to 1 Jun 2025
- 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 1 day to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: ICU patients worldwide
Who may be able to join
- All patients admitted to an ICU between the years 2005-2023
Who cannot join
- Patients without ICU admission or ICU admission < 4 hours
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Anesthesiology and Intensive Care Medicine
Cologne, North Rhine-Westphalia, 50937
Sandra E Stoll, MD, +491735697566, sandraemilystoll@googlemail.com
Sandra E Stoll, MD, +491735697566 ext. Stoll, sandra-emily.stoll@gmx.de
About this study
Official title: Prognostication of ICU- and Ventilator- Days Over the Next Years Until 2040 Using Statistical Projection Models and Retrospective Data From International Databases From 2005-2023 (PrognostICate- Study).
The Objective of this retrospective multicenter- study is to forecast Intensive Care Unit (ICU) length of stay (ICULOS) and length of mechanical ventilation (LOMV) in ICU patients of different groups (regarding gender, age group, medical vs surgical admission) worldwide for the next years up to the year of 2040 using statistical forecasting models and historical, national and international ICU databases and population databases.
Read the detailed description
Adequate resource allocation in Intensive Care Medicine is especially challenging due to limited resources and increasing demands for ICU capacities due to an aging population and medical advances. Several studies in the past were trying to predict ICULOS using different models. The Objective and aim of our retrospective multicenter study are to forecast ICU length of stay (ICULOS) and length of mechanical ventilation (LOMV) in ICU patients of different groups (regarding gender, age group, medical vs surgical admission) worldwide for the next years up to the year of 2040 using statistical forecasting models.
To achieve this objective, historical ICU data spanning from 2005 to 2023 is collected from international ICU databases worldwide as well as population data from national and international databases and employ different statistical forecasting models (ARIMA-Model (Auto-Regressive Integrated Moving Average), logistic regression, Poisson Regression and ETS (Exponential smoothing)) to make these predictions. The Validity of the 4 different models is assessed with out-of-time-cross validity by splitting the data in 2 subsets for generation and testing of the model in a ratio of approximately 75:25 of the dataset. The most valid model of the 4 different models will be chosen. The statistical analysis follows he guidelines for Accurate and Transparent Health Estimates Reporting (GATHER Statement) von Stevens et al. from the year 2016.
The ultimate goal of this project is to provide valuable insights to healthcare system decision-makers worldwide regarding future requirements of ICU beds and ventilator capacities. With this insight we want to enable healthcare- system decision makers worldwide to proactively anticipate and allocate appropriate ICU resources for the future.
- Conditions
- ICU Admission
- Being tested
- Intensive Care Unit (ICU) treatment
- Keywords
- Length of ICU stay, Length of mechanical ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Care Unit (ICU) treatmentOther
Also called ICU treatment
ICU treatment
| Study group | Role | What they receive |
|---|---|---|
| ICU patients | All ICU patients in different countries worldwide from 2005-2023 Receives: Other: Intensive Care Unit (ICU) treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of mechanical ventilation
Forecasting mechanical ventilation for the next 16 years
Measured: 2024-2040
Length of ICU stay
Forecasting ICU stay for the next 16 years
Measured: 2024-2040
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start1 Mar 2024
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ICU AdmissionStudies 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
- 10,000,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Cologne
- Sponsor type
- University, hospital or other
- Collaborators
- Johann Wolfgang Goethe University Hospital, Monash University, The Alfred, Albert Einstein College of Medicine
- Responsible party
- Principal investigator, Sandra Emily Stoll, University Hospital of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06289075
- Sponsor's protocol ID
- 23-1096-retro
- Acronym
- PrognostICate
- Status last verified
- Jul 2024
- First submitted
- 24 Feb 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostication of ICU- and Ventilator- Days Over the Next Years Until 2040 Using Statistical Projection Models and Retrospective Data From International Databases From 2005-2023 (PrognostICate- Study).
- ClinicalTrials.gov ID
- NCT06289075
- Acronym / sponsor ID
- PrognostICate / 23-1096-retro
- Conditions
- ICU Admission
- Keywords
- Length of ICU stay, Length of mechanical ventilation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000,000 participants (estimated)
- Lead sponsor
- University Hospital of CologneUniversity, hospital or other
- Collaborators
- Johann Wolfgang Goethe University Hospital, Monash University, The Alfred, Albert Einstein College of Medicine
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 1 Mar 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.
The Objective of this retrospective multicenter- study is to forecast Intensive Care Unit (ICU) length of stay (ICULOS) and length of mechanical ventilation (LOMV) in ICU patients of different groups (regarding gender, age group, medical vs surgical admission) worldwide for the next years up to the year of 2040 using statistical forecasting models and historical, national and international ICU databases and population databases.
Detailed description
Adequate resource allocation in Intensive Care Medicine is especially challenging due to limited resources and increasing demands for ICU capacities due to an aging population and medical advances. Several studies in the past were trying to predict ICULOS using different models. The Objective and aim of our retrospective multicenter study are to forecast ICU length of stay (ICULOS) and length of mechanical ventilation (LOMV) in ICU patients of different groups (regarding gender, age group, medical vs surgical admission) worldwide for the next years up to the year of 2040 using statistical forecasting models.
To achieve this objective, historical ICU data spanning from 2005 to 2023 is collected from international ICU databases worldwide as well as population data from national and international databases and employ different statistical forecasting models (ARIMA-Model (Auto-Regressive Integrated Moving Average), logistic regression, Poisson Regression and ETS (Exponential smoothing)) to make these predictions. The Validity of the 4 different models is assessed with out-of-time-cross validity by splitting the data in 2 subsets for generation and testing of the model in a ratio of approximately 75:25 of the dataset. The most valid model of the 4 different models will be chosen. The statistical analysis follows he guidelines for Accurate and Transparent Health Estimates Reporting (GATHER Statement) von Stevens et al. from the year 2016.
The ultimate goal of this project is to provide valuable insights to healthcare system decision-makers worldwide regarding future requirements of ICU beds and ventilator capacities. With this insight we want to enable healthcare- system decision makers worldwide to proactively anticipate and allocate appropriate ICU resources for the future.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU patients | – | Other: Intensive Care Unit (ICU) treatmentAll ICU patients in different countries worldwide from 2005-2023 |
Who may qualify
- Ages
- 1 day to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- ICU patients worldwide
Key inclusion criteria (1 listed)
- All patients admitted to an ICU between the years 2005-2023
Key exclusion criteria (1 listed)
- Patients without ICU admission or ICU admission < 4 hours
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 |
|---|---|---|
| Intensive Care Unit (ICU) treatmentAlso: ICU treatmentICU treatment | Other | ICU patients |
Primary outcome
Length of mechanical ventilation
Time frame: 2024-2040
Forecasting mechanical ventilation for the next 16 years
Length of ICU stay
Time frame: 2024-2040
Forecasting ICU stay for the next 16 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Individual participant dataSharing planned: No
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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.
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 ICU Admission, run by University Hospital of Cologne at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 23 Jul 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sandra Emily Stoll, DR. AP (+491735697566, sandraemilystoll@googlemail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of mechanical ventilation (time frame: 2024-2040). The study lists 2 primary outcomes in all. 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 23 Jul 2024.