PACESIM

• Research type

  Research Study

• Full title

  Building a High-Fidelity Temporary Pacing Simulator and Automatic Alerting Tool

• IRAS ID

  292373

• Contact name

  Mark Mason

• Contact email

  m.mason@rbht.nhs.uk

• Sponsor organisation

  Guy's and St Thomas' NHS Foundaiton Trust, Royal Brompton and Harefield Hospitals

• Duration of Study in the UK

  2 years, 6 months, 6 days

• Research summary

  Background:
  All patients at Harefield Hospital undergoing open-heart surgery have a temporary pacemaker inserted during the operation because electrical conduction disturbance is common.

  Temporary pacing management can be complicated because certain parameters change quickly and failure to program the pacemaker settings accordingly can result in lower blood pressures or dangerous heart rhythms. Therefore, temporary pacemakers require daily checks.

  However, there is limited standardised training in temporary pacemaker management in the UK and no simulator training.

  Aims:
  1. To create a pacing simulator to train doctors how best to manage and adjust temporary pacemakers

  2. To build an automatic alarm system to detect poor pacemaker settings and clearly show how to adjust the settings correctly

  Method of Investigation:
  We will recruit patients at Harefield Hospital who are undergoing cardiac surgery for Coronary Artery Bypass Grafting (CABG) and/or Aortic, Mitral and Tricuspid Valve surgery. Patients with all levels of heart function (including those with normal heart function and severely impaired heart function) will be included as the aim is to build a simulator and correction algorithm that is applicable to a wide array of patients.

  We will recruit 25 patients at Harefield Hospital who already have temporary pacemakers after cardiac surgery. We will then perform the usual safety checks on enrolled participants within 72 hours of surgery and modify the pacemaker settings to find the settings that achieve the highest blood pressure.

  During the setting changes we will record a number of measurements. Blood pressure will be measured via an arterial line (a plastic tube inserted into an artery in the wrist that directly measures the blood pressure) and also via a device that measures blood pressure with a sensor placed on the fingertip. The electrical activity of the heart will be measured by electrodes placed on the surface of the chest, otherwise known as an electrocardiogram (ECG). A set of tubing inserted into one of the large veins in the neck will measure pressure in the veins. Finally, ultrasound images of the heart (an echocardiogram) will also be taken during the setting changes to measure, amongst other things, how quickly blood is travelling in the heart using different settings.

  The collection of data from each participant will take 1-2 hours. They will undergo no additional invasive procedures. The collection of data will take less than one year.

  Once the data is collected, we will analyse the data using a variety of machine learning techniques to identify features that define the traces as safe vs unsafe and optimal or suboptimal. Once this data is collected it can be used to create the automatic detection algorithm and form the basis of the simulator. The data analysis will be performed using anonymised data. The analysis and simulator building will be performed by the Study Coordinator (Dr Alexander Tindale) at Imperial College London and Brunel University alongside colleagues at those institutions.
  

• REC name

  South West - Cornwall & Plymouth Research Ethics Committee

• REC reference

  21/SW/0051

• Date of REC Opinion

  30 Apr 2021

• REC opinion

  Favourable Opinion