The ACUTE (Ambulance CPAP: Use, Treatment effect and Economics) feasibility study: a pilot randomised controlled trial of prehospital CPAP for acute respiratory failure

Fuller GW, Keating S, Goodacre S, Herbert E, Perkins GD, Rosser A, Gunson I, Miller J, Ward M, Bradburn M, Thokala P, Harris T, Marsh M M, Scott AJ, Cooper C
Record ID 32016000877
English
Authors' objectives: Acute respiratory failure is a common and life-threatening medical emergency that often results in prolonged hospital stays or expensive intensive care admissions. It occurs when heart or lung disease suddenly develops or worsens and leads to the patient being unable to maintain oxygen levels in their blood. When this happens the patient is at high risk of death and needs emergency treatment. Paramedics currently provide oxygen delivered at normal pressure by a loose fitting face mask. Continuous positive airway pressure (CPAP) is a potentially useful treatment that could be delivered by paramedics in an ambulance. It involves delivering oxygen under increased pressure through a tight-fitting facemask. Its use in hospital can reduce the risk of death in people with lung disease and improve breathing in people with heart disease. Small studies undertaken outside the UK have suggested that using CPAP in an ambulance may save more lives than delaying its use until arrival at hospital. However, it is uncertain whether this treatment could work effectively in NHS ambulance services, and if it represents value for money. AIM The purpose of this study is to see whether it is possible and worthwhile to undertake a full-scale study comparing CPAP and standard oxygen treatment for acute respiratory failure, and if so, how we should do it. METHODS Paramedics will identify adults with acute respiratory failure when attending 999 emergency calls. We aim to include 120 patients in the study. Half will be randomly assigned to a group that will receive CPAP, while the other half will be treated with standard oxygen therapy. All the patients will then undergo normal hospital treatment and be followed up for a month to see if they survive. We will also measure each patient s quality of life, need for admission to intensive care, and length of stay in hospital. Additionally, we will look at how many adults are attended with acute respiratory failure and are entered into study, the number who correctly receive CPAP treatment, and how many patients we can follow up to the end of the study. Paramedics will also be surveyed to understand their experience of delivering CPAP and aspects of the research. Together these results will tell us whether it is feasible and affordable to conduct a full -scale study evaluating CPAP for acute respiratory failure, and will inform us how to design it. The main ethical issue is that the trial will involve patients who are severely ill and unable to decide whether they wish to participate. In these circumstances patients can be recruited to the trial and their consent sought later, provided important legal safeguards are adhered to. We have consulted with representatives from relevant patient groups to ensure that this process respects the patient's dignity and autonomy. EXPERTISE Our research team has extensive experience of undertaking trials of emergency treatments and is familiar with the complex ethical and legal issues when undertaking these studies. People who have experienced medical emergencies and breathing problems have been consulted in the development of this project. We will continue to involve patient and public representatives to ensure that the needs of potentially vulnerable patients are taken into account throughout the study
Details
Project Status: Completed
Year Published: 2021
English language abstract: An English language summary is available
Publication Type: Not Assigned
Country: England
MeSH Terms
  • Continuous Positive Airway Pressure
  • Ambulances
  • Emergency Medical Services
  • Feasibility Studies
  • Respiratory Distress Syndrome
  • Respiratory Insufficiency
  • Emergency Medical Technicians
Contact
Organisation Name: NIHR Health Technology Assessment programme
Contact Address: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK
Contact Name: journals.library@nihr.ac.uk
Contact Email: journals.library@nihr.ac.uk
Copyright: Queen's Printer and Controller of HMSO
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