Building a realistic pacing simulator
| ISRCTN | ISRCTN15383573 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15383573 |
| IRAS number | 292373 |
| Secondary identifying numbers | CPMS 49062, IRAS 292373 |
- Submission date
- 19/08/2021
- Registration date
- 01/09/2021
- Last edited
- 09/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English Summary
Background and study aims
A pacemaker is a small electrical device used to treat some abnormal heart rhythms (arrhythmias) that can cause your heart to either beat too slowly or miss beats.
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
Who can participate?
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.
What does the study involve?
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.
What are the possible benefits and risks of participating?
Benefits: None
Risks: The only disadvantage is the time commitment during the data collection of one to two hours rather than the usual 15 minutes for a temporary pacemaker check. During the check we will also use the echocardiogram machine which uses ultrasound to take images of the heart from outside the chest wall.
Where is the study run from?
Harefield Hospital (UK)
When is the study starting and how long is it expected to run for?
October 2020 to March 2023
Who is funding the study?
Royal Brompton and Harefield NHS Trust (UK)
Who is the main contact?
Dr Alexander Tindale, a.tindale@rbht.nhs.uk
Contact information
Public
Harefield Hospital
Hill End Road
London
UB9 6JH
United Kingdom
 ORCID ID |
0000-0002-8199-4275 |
|---|---|
| Phone | +44 (0)1895828317 |
| a.tindale@rbht.nhs.uk |
Scientific
Harefield Hospital
Hill End Road
Harefield
Uxbridge
UB9 6JH
United Kingdom
| Phone | +44 (0)1895828317 |
|---|---|
| a.tindale@rbht.nhs.uk |
Study information
| Study design | Observational non-randomized |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | 40302 PIS+-+PACESIM_V1.2_03May2021.docx |
| Scientific title | Building a high-fidelity temporary pacing simulator and automatic alerting tool |
| Study acronym | PACESIM |
| Study hypothesis | 1. By collecting and analysing data using machine learning techniques from patients with optimal and suboptimal pacing modes, I will build a simulator to train healthcare professionals to optimise pacing in individual patients 2. The same dataset can be used to create an algorithm that will allow automatic adjustments of temporary pacing outputs to optimise haemodynamic parameters |
| Ethics approval(s) | Approved 05/05/2021, South West - Cornwall & Plymouth Research Ethics Committee (Level 3, Block B. Whitefriars, Lewins Mead, Bristol BS1 2NT, UK; +44 (0)207 104 8071; cornwallandplymouth.rec@hra.nhs.uk), ref: 21/SW/0051 |
| Condition | Optimising and recording data from patients using temporary pacemakers after cardiac surgery with the aim of building a pacing simulator |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure | Accuracy of arrhythmia classification by percentage correct compared to diagnosis from clinician from recordings taken during the pacemaker optimisation |
| Secondary outcome measures | Improvement in confidence of clinicians in adjusting temporary pacemaker after using the simulator compared to before using the simulator, as measured by the Student Satisfaction and Self-Confidence in Learning Scale (SCLS) |
| Overall study start date | 31/10/2020 |
| Overall study end date | 22/03/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 25 |
| Participant inclusion criteria | 1. Aged over 18 years 2. Undergoing open cardiac surgery: Coronary Artery Bypass Surgery (CABG), aortic, mitral and tricuspid valve surgery, or combinations of the above, that will require the placing of temporary epicardial wires 3. Any left ventricular function 4. Ability to give valid consent |
| Participant exclusion criteria | 1. Aged under 18 years 2. Inability to give informed consent 3. Permanent pacemaker already in situ |
| Recruitment start date | 01/07/2021 |
| Recruitment end date | 01/07/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Uxbridge
UB9 6JH
United Kingdom
Sponsor information
Hospital/treatment centre
Harefield Hospital
Hill End Road
Harefield
Uxbridge
UB9 6JH
England
United Kingdom
| Phone | +44 (0)1895828317 |
|---|---|
| research@rbht.nhs.uk | |
| Website | https://www.rbht.nhs.uk/research/research-office |
"ROR" |
https://ror.org/02218z997 |
Funders
Funder type
Hospital/treatment centre
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Royal Brompton & Harefield NHS Foundation Trust
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/02/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1.2 | 03/05/2021 | 19/08/2021 | No | Yes |
| HRA research summary | 28/06/2023 | No | No | ||
| Other publications | A comparison of different methods to maximise signal extraction when using central venous pressure to optimise atrioventricular delay after cardiac surgery | 01/04/2024 | 09/10/2024 | Yes | No |
Additional files
Editorial Notes
09/10/2024: Publication reference added.
24/03/2023: The following changes have been made and the plain English summary updated accordingly:
2. The overall trial end date has been changed from 31/10/2022 to 22/03/2023.
3. The intention to publish date has been changed from 01/02/2023 to 01/02/2024.
17/09/2021: Internal review.
19/08/2021: Trial's existence confirmed by the National Institute for Health Research (NIHR) (UK).
