Respiratory Distress Syndrome, AdultPSTOTICUNCT04297397
Personalised Simulation Technologies for Optimising Treatment in the Intensive Care Unit
An observational study of Respiratory Distress Syndrome, Adult and Respiratory Insufficiency, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This project aims to develop software models describing how critically ill patients respond to changes in their treatment whilst admitted to an Intensive Care Unit (ICU). We will use high performance computers to fit software models to the physiological and treatment data of patients receiving mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Respiratory Distress Syndrome, Adult, Respiratory Insufficiency
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Feb 2020to 31 May 2022
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be drawn from the adult critical care population at GSTFT. Subjects of interest are those receiving mechanical ventilation.
Who may be able to join
- At least 18 years of age
- Patients admitted to GSTFT Intensive Care between the dates 01/01/2010 and 31/03/2019
- Receiving mechanical ventilation
Who cannot join
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Guys & St. Thomas' NHS Foundation Trust
London, SE1 7EH
About this study
This project aims to develop software models describing how critically ill patients respond to changes in their treatment whilst admitted to an Intensive Care Unit (ICU). We will use high performance computers to fit software models to the physiological and treatment data of patients receiving mechanical ventilation.
Read the detailed description
In the United Kingdom, approximately 142,000 people are admitted to ICU each year. A large proportion, 10 - 20%, of these patients have a life-threatening respiratory illness called Acute Respiratory Distress Syndrome (ARDS). These patients need specialist help with their breathing, from a machine called a ventilator. Only seven out of ten patients will survive this illness and even survival may bring ongoing problems, sometimes for a long time after leaving hospital.
Accurate mathematical and computer models of ARDS, would allow investigation of the illness outside of the ICU and inside the virtual environment of a computer. Different treatments could be simulated on the same 'virtual' patient, or the same treatment on many different patients with varying degrees of illness.
Development of these software models, requires collection of a library of data describing how patients respond to changes in their treatment. An example would be to describe how a patient's blood pressure responds to a change in the settings of their ventilator. The changes to a patient's ventilation would be made as part of the normal care provided by the doctors and nurses looking after them.
Mathematical descriptions have been created before, from simpler data sets which were essentially single snapshots of a patient's condition and treatment. The investigators aim to capture sequences of snapshots over several hours, allowing them to build more accurate models.
Guy's and St Thomas' NHS Foundation Trust (GSTFT) is the clinical partner of the project. Patients would be identified there by clinical researchers, who would then collect the data describing their treatment. This data would be anonymised before adding to the library of data to be shared with academic researchers.
Academic members of the team at the University of Warwick and the University of Nottingham possess the engineering and mathematical expertise needed to develop the complex software models. They also provide the facility of a high performance computing cluster necessary for the difficult process of fitting models to the data.
Once the software models have been built and used to examine the how treatment might be improved, the findings would be shared with clinical staff around the world, through the publication of articles in medical journals. It is possible that the insights gained by the modelling process might inform, change and improve how clinical staff use ventilators to support patients with ARDS.
- Keywords
- ICU, Patient Simulation, Critical Care, ARDS, Mechanical Ventilation
- Medical subject headings
- Respiratory Distress Syndrome, Respiratory Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of a simulation platform
Develop predictive physiological models and simulation platform in mechanically ventilated patients with ARDS
Measured: 2 years
Secondary outcomes (2)
Development of dynamic modelling with integration of real time ICU data streams
To integrate data-streams available in the ICU with our existing physiological modelling algorithms to enable real-time simulation of treatment response.
Measured: 2 years
Exploration of therapeutic intervention design space
To develop mathematical methods to explore the "design space" for a clinical support system.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start20 Feb 2020
- Primary completion30 Apr 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress Syndrome, AdultStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nottingham, University of Warwick
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04297397
- Sponsor's protocol ID
- 266780PSTOTICU
- Other IDs
- EP/P023444/1
- Acronym
- PSTOTICU
- Status last verified
- Jul 2023
- First submitted
- 4 Mar 2020
- Last updated
- 11 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chikhani M, Das A, Haque M, Wang W, Bates DG, Hardman JG. High PEEP in acute respiratory distress syndrome: quantitative evaluation between improved arterial oxygenation and decreased oxygen delivery. Br J Anaesth. 2016 Nov;117(5):650-658. doi: 10.1093/bja/aew314.
PubMed 27799180Das A, Cole O, Chikhani M, Wang W, Ali T, Haque M, Bates DG, Hardman JG. Evaluation of lung recruitment maneuvers in acute respiratory distress syndrome using computer simulation. Crit Care. 2015 Jan 12;19(1):8. doi: 10.1186/s13054-014-0723-6.
PubMed 25578295Das A, Haque M, Chikhani M, Cole O, Wang W, Hardman JG, Bates DG. Hemodynamic effects of lung recruitment maneuvers in acute respiratory distress syndrome. BMC Pulm Med. 2017 Feb 8;17(1):34. doi: 10.1186/s12890-017-0369-7.
PubMed 28178996Flechelles O, Ho A, Hernert P, Emeriaud G, Zaglam N, Cheriet F, Jouvet PA. Simulations for mechanical ventilation in children: review and future prospects. Crit Care Res Pract. 2013;2013:943281. doi: 10.1155/2013/943281. Epub 2013 Mar 7.
PubMed 23533735
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalised Simulation Technologies for Optimising Treatment in the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT04297397
- Acronym / sponsor ID
- PSTOTICU / 266780PSTOTICU
- Keywords
- ICU, Patient Simulation, Critical Care, ARDS, Mechanical Ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Nottingham, University of Warwick
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 5 Mar 2020 (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.
This project aims to develop software models describing how critically ill patients respond to changes in their treatment whilst admitted to an Intensive Care Unit (ICU). We will use high performance computers to fit software models to the physiological and treatment data of patients receiving mechanical ventilation.
Detailed description
In the United Kingdom, approximately 142,000 people are admitted to ICU each year. A large proportion, 10 - 20%, of these patients have a life-threatening respiratory illness called Acute Respiratory Distress Syndrome (ARDS). These patients need specialist help with their breathing, from a machine called a ventilator. Only seven out of ten patients will survive this illness and even survival may bring ongoing problems, sometimes for a long time after leaving hospital.
Accurate mathematical and computer models of ARDS, would allow investigation of the illness outside of the ICU and inside the virtual environment of a computer. Different treatments could be simulated on the same 'virtual' patient, or the same treatment on many different patients with varying degrees of illness.
Development of these software models, requires collection of a library of data describing how patients respond to changes in their treatment. An example would be to describe how a patient's blood pressure responds to a change in the settings of their ventilator. The changes to a patient's ventilation would be made as part of the normal care provided by the doctors and nurses looking after them.
Mathematical descriptions have been created before, from simpler data sets which were essentially single snapshots of a patient's condition and treatment. The investigators aim to capture sequences of snapshots over several hours, allowing them to build more accurate models.
Guy's and St Thomas' NHS Foundation Trust (GSTFT) is the clinical partner of the project. Patients would be identified there by clinical researchers, who would then collect the data describing their treatment. This data would be anonymised before adding to the library of data to be shared with academic researchers.
Academic members of the team at the University of Warwick and the University of Nottingham possess the engineering and mathematical expertise needed to develop the complex software models. They also provide the facility of a high performance computing cluster necessary for the difficult process of fitting models to the data.
Once the software models have been built and used to examine the how treatment might be improved, the findings would be shared with clinical staff around the world, through the publication of articles in medical journals. It is possible that the insights gained by the modelling process might inform, change and improve how clinical staff use ventilators to support patients with ARDS.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be drawn from the adult critical care population at GSTFT. Subjects of interest are those receiving mechanical ventilation.
Key inclusion criteria (3 listed)
- At least 18 years of age
- Patients admitted to GSTFT Intensive Care between the dates 01/01/2010 and 31/03/2019
- Receiving mechanical ventilation
Key exclusion criteria (1 listed)
- Pregnancy or lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Development of a simulation platform
Time frame: 2 years
Develop predictive physiological models and simulation platform in mechanically ventilated patients with ARDS
2 secondary outcomes
Development of dynamic modelling with integration of real time ICU data streams
Time frame: 2 years
Exploration of therapeutic intervention design space
Time frame: 2 years
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 11 Jul 2023.
- Background: PubMed 27799180Chikhani M, Das A, Haque M, Wang W, Bates DG, Hardman JG. High PEEP in acute respiratory distress syndrome: quantitative evaluation between improved arterial oxygenation and decreased oxygen delivery. Br J Anaesth. 2016 Nov;117(5):650-658. doi: 10.1093/bja/aew314.
- Background: PubMed 25578295Das A, Cole O, Chikhani M, Wang W, Ali T, Haque M, Bates DG, Hardman JG. Evaluation of lung recruitment maneuvers in acute respiratory distress syndrome using computer simulation. Crit Care. 2015 Jan 12;19(1):8. doi: 10.1186/s13054-014-0723-6.
- Background: PubMed 28178996Das A, Haque M, Chikhani M, Cole O, Wang W, Hardman JG, Bates DG. Hemodynamic effects of lung recruitment maneuvers in acute respiratory distress syndrome. BMC Pulm Med. 2017 Feb 8;17(1):34. doi: 10.1186/s12890-017-0369-7.
- Background: PubMed 23533735Flechelles O, Ho A, Hernert P, Emeriaud G, Zaglam N, Cheriet F, Jouvet PA. Simulations for mechanical ventilation in children: review and future prospects. Crit Care Res Pract. 2013;2013:943281. doi: 10.1155/2013/943281. Epub 2013 Mar 7.
- Individual participant dataSharing planned: No
Related trials for Respiratory Distress Syndrome, Adult
Not yet recruitingObservational study
Early Switch in Moderate ARDS
Acute Respiratory Distress Syndrome (ARDS)
RecruitingPhase 3
Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen
Viral Lung Infection and Acute Respiratory Failure
RecruitingPhase 2
PirfenidoneVsPlacebo as Prophylaxis Against Acute Radiation-induced Lung Injury Following HFRT in Breast Cancer Patients
Acute Lung Injury, Prevention
Not yet recruiting
The Hemodynamic Impact of High-frequency Oscillatory Ventilation and Periodic Sighs in Preterm Infants
Preterm, Respiratory Distress Syndrome in Premature Infant
Not yet recruitingPhase 2
Fostamatinib for Treating Acute Respiratory Distress Syndrome (ARDS) in Hospitalized Adults
Acute Respiratory Distress Syndrome, ARDS
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Respiratory Distress Syndrome, Adult and Respiratory Insufficiency, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
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 3 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: finished, as of the sponsor's last update on 11 Jul 2023. 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 United Kingdom. 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?
Development of a simulation platform (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04297397, which also lists 4 linked publications.
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 11 Jul 2023.