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CompletedNCT04297397PSTOTICUUpdated Jul 11, 2023

Personalised Simulation Technologies for Optimising Treatment in the Intensive Care Unit

An observational study in Respiratory Distress Syndrome, Adult and Respiratory Insufficiency, sponsored by Guy's and St Thomas' NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-07-11.

Sponsored by Guy's and St Thomas' NHS Foundation Trust · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
25
Ages
18 Years to 100 Years
Sex
All
01

Study 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 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.

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Conditions studied

  • Respiratory Distress Syndrome, Adult
  • Respiratory Insufficiency

Keywords

  • ICU
  • Patient Simulation
  • Critical Care
  • ARDS
  • Mechanical Ventilation
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In context

Respiratory Distress Syndrome

1,619 studies on the registry are indexed under Respiratory Distress Syndrome; 319 are open to participants now.

This study's enrollment of 25 is below the median of 100 across 548 observational studies indexed under Respiratory Distress Syndrome.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust is the lead sponsor of 294 studies on the registry; 79 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Subjects will be drawn from the adult critical care population at GSTFT. Subjects of interest are those receiving mechanical ventilation.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Pregnancy or lactation
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Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
25 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Development of a simulation platform

    Develop predictive physiological models and simulation platform in mechanically ventilated patients with ARDS

    Time frame: 2 years

Secondary outcomes

  1. 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.

    Time frame: 2 years

  2. Exploration of therapeutic intervention design space

    To develop mathematical methods to explore the "design space" for a clinical support system.

    Time frame: 2 years

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Study locations

1 site
  • Guys & St. Thomas' NHS Foundation Trust
    London, SE1 7EH, United Kingdom
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References and documents

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 27799180 ↗
  • Das 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 25578295 ↗
  • Das 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 28178996 ↗
  • Flechelles 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 documents

  • Study protocol · Feb 5, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 11, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04297397
Collaborators
University of Nottingham, University of Warwick
Responsible party
Sponsor
First posted
Mar 5, 2020
Start date
Feb 20, 2020
Primary completion
Apr 30, 2022
Completion
May 31, 2022
Last update
Jul 11, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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