Personalised Simulation Technologies for Optimising Treatment in the Intensive Care Unit (PSTOTICU)

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Insufficiency; Respiratory Distress Syndrome, Adult

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 Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

• Study Contact: Name: Luigi Camporota, MD; Phone Number: 00442071883046; Email: luigi.camporota@gstt.nhs.uk
• Study Contact Backup: Name: Barnaby Sanderson, BSc; Phone Number: 00442071883046; Email: barnaby.sanderson@gstt.nhs.uk

Study Locations

• United Kingdom
  • London, United Kingdom, SE1 7EH
    • Guys & St. Thomas' NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• 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.

Description

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:

• Pregnancy or lactation

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Development of a simulation platform	Develop predictive physiological models and simulation platform in mechanically ventilated patients with ARDS	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years
Exploration of therapeutic intervention design space	To develop mathematical methods to explore the "design space" for a clinical support system.	2 years

Collaborators and Investigators

• Sponsor: Guy's and St Thomas' NHS Foundation Trust
• Collaborators: University of Nottingham; University of Warwick

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2020
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: March 4, 2020
• First Submitted That Met QC Criteria: March 4, 2020
• First Posted (Actual): March 5, 2020

Study Record Updates

• Last Update Posted (Actual): July 11, 2023
• Last Update Submitted That Met QC Criteria: July 10, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: ICU; ARDS; Mechanical Ventilation; Critical Care; Patient Simulation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Respiratory Insufficiency; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: 266780PSTOTICU; EP/P023444/1 (Other Identifier: EPSRC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No