NCT04297397

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2020

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 5, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
Last Updated

July 11, 2023

Status Verified

July 1, 2023

Enrollment Period

2.2 years

First QC Date

March 4, 2020

Last Update Submit

July 10, 2023

Conditions

Keywords

ICUPatient SimulationCritical CareARDSMechanical Ventilation

Outcome Measures

Primary Outcomes (1)

  • Development of a simulation platform

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

    2 years

Secondary Outcomes (2)

  • Development of dynamic modelling with integration of real time ICU data streams

    2 years

  • Exploration of therapeutic intervention design space

    2 years

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guys & St. Thomas' NHS Foundation Trust

London, SE1 7EH, United Kingdom

Location

Related Publications (4)

  • 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.

    PMID: 27799180BACKGROUND
  • 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.

    PMID: 25578295BACKGROUND
  • 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.

    PMID: 28178996BACKGROUND
  • 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.

    PMID: 23533735BACKGROUND

MeSH Terms

Conditions

Respiratory Distress SyndromeRespiratory Insufficiency

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2020

First Posted

March 5, 2020

Study Start

February 20, 2020

Primary Completion

April 30, 2022

Study Completion

May 31, 2022

Last Updated

July 11, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations