1. The ACUTE Trial Session 1: Introduction to the ACUTE Trial
Ambulance CPAP Use, Treatment Effect and Economics
Session 1: Introduction to the ACUTE Trial
Hello.
My name is Gordon Fuller.
I’m an Emergency Medicine registrar working in South Yorkshire and a clinical lecturer working in the Centre for Urgent and Emergency Care Research at the University of Sheffield.
Thank you very much for your interest in the ACUTE trial and welcome to the ACUTE study online training modules.
There are 3 short training sessions that must be completed before you are able to participate in the study.
These are:
This introductory module which gives background information about the trial and research team.
A clinical module describing acute respiratory failure and non-invasive ventilation
And a study procedures session which covers capacity, consent, patient recruitment and data collection.
The modules can be completed in any order, and you can pause, rewind, return to, or re-start the modules at any point.
Each module should take between 10 and 20 minutes to complete.
Once you have completed the modules please contact the ACUTE trial research paramedics Josh and Imogen who will organise sign off and answer any outstanding questions.
We hope you enjoy learning about the ACUTE trial and look forward to working with you on the study.
he opportunity to talk to you about the ACUTE trial which is a HTA funded pilot study testing the feasibility of conducting a randomised controlled trial to evaluate the use of prehospital CPAP in acute respiratory failure.

2. The ACUTE Trial – What?
Acute respiratory failure is common, life threatening and expensive
The best pre-hospital treatment is uncertain
The ACUTE trial is a pilot randomised controlled trial comparing:
CPAP
Standard oxygen therapy
Funded by the National Institute of Health Research
So what is the ACUTE study?
The ACUTE trial is a pilot randomised controlled trial that will compare standard oxygen therapy and paramedic delivered CPAP treatment in acute respiratory failure (ARF). The aim of the study is to see whether its feasible to conduct a large scale definitive trial to see which treatment in better. The specific things we’ll be looking at are:
How many patients present with ARF
Are ambulance clinicians willing to recruit patients into the trial
Are patients willing to enter into the study
Will ambulance clinicians provide CPAP treatment
Are we able to collect data and follow up patient outcomes
Together this information will tell us whether its worth continuing on to a much bigger final study.
The problem we will be looking at is acute respiratory failure; a common and life-threatening medical emergency which occurs when cardiac or pulmonary disease lead to failure to maintain adequate blood oxygen levels (hypoxia) and/or increased blood carbon dioxide levels (hypercarbia). It is caused by a number of common conditions, including heart failure, pneumonia, COPD, pulmonary embolism and asthma.
Currently its uncertain whether standard treatment with oxygen is best, or whether CPAP a form of non-invasive ventilation is better. A number of small trials from outside of the UK have suggested CPAP may be superior, but we cannot be sure based on the current evidence.
Ultimately we’ll be looking at patient survival as the most important outcome measure. We’ll also compare how many patients are admitted to intensive care and quality of life.
The study is being funded by the English Department of Health through the National Institute of Health Research’s Health Technology Assessment Programme. 2

3. The ACUTE Trial – Who?
A collaboration between the University of Sheffield and West Midlands Ambulance Service
Chief Investigators: Trial Manager:
The ACUTE study is a collaboration between the University of Sheffield and West Midlands Ambulance Service.
The trial is being led by 2 co-chief-investigators:
Myself, Dr Gordon Fuller
And Professor Goodacre – an Emergency Medicine consultant at the Northern General Hospital and Professor at the University of Sheffield. He is a very experienced researcher and had been involved in previous clinical trials of CPAP and prehospital studies.
The trial is being supported by the University of Sheffield clinical trials unit. Dr Sam Keating is a doctor working as the study manager working from the clinical trials unit.
Professor Steve Goodacre
Dr Sam Keating
Dr Gordon Fuller 3

4. The ACUTE Trial – Who?
WMAS co-investigators:  WMAS Research paramedics:
Matt Ward and Andy Rosser are members of the study team from the West Midlands Ambulance Service. They are very experienced have collaborated on major pre-hospital trials such as PARAMEDIC and PARAMEDIC 2.
There are two research paramedics working full time on the ACUTE study Josh Miller and Imogen Gunson. They will be helping with organising patient randomisation, data collection and troubleshooting any problems arising in the trial. Josh and Imogen should be your first port of call with any questions or issues relating to the ACUTE trial.
Other key co-investigators are Professor Gavin Perkins, an intensive care consultant at Heartlands Hospitals, Professor Tim Harris an emergency medicine consultant at Barts, in London, and statisticians and data management staff at Sheffield Clinical Trials Unit.
Matt Ward
Andy Rosser
Josh Miller
Imogen Gunson 4

5. The ACUTE Trial – Where and When?
STOKE
STAFFORD
LICHFIELD
erdington
The trial will be conducted in 4 ambulance hubs in the West Midlands.
Three hubs are in Staffordshire and comprise Stafford, Stoke and Litchfield.
One hub is in north Birmingham at Erdington.
Trial set up processes began in the summer of We aim to train WMAS paramedics during the summer of 2017 and aim to begin recruitment in August 2017.
We will enrol patients into the study for 1 year, before analysing the data.
August 2017 to July 2018 5

6. The ACUTE Trial – Further Information
Twitter
There are 2 further training modules that will give further information about the ACUTE study:
A clinical module will cover the causes, effects and treatment of acute respiratory failure. This will also describe how to use CPAP.
Finally, a research module will cover the recruitment, consent and data collection processes for the ACUTE trial.
There is a study website available through the University of Sheffield which has detailed information on the trial including the study protocol and contact details.
We also have a Twitter account for trial updates.
The research paramedics are excellent contacts for any queries or problems with the ACUTE trial. Their and telephone details are shown on the screen, or are available from the ACUTE website.
Sam, the trial manager would also be delighted to help with any questions. 6

7. The ACUTE Trial Thankyou
Thank you very much for your attention.
Please now complete the remaining training modules.
We look forward to working with you on the ACUTE trial.