Ambulance CPAP: Use, Treatment Effect and Economics feasibility study
Research type
Research Study
Full title
The ACUTE (Ambulance CPAP: Use, Treatment Effect and Economics) feasibility study: A pilot randomised controlled trial of prehospital CPAP for acute respiratory failure
IRAS ID
201429
Contact name
Gordon Fuller
Contact email
Sponsor organisation
University of Sheffield
ISRCTN Number
ISRCTN12048261
Duration of Study in the UK
1 years, 4 months, 0 days
Research summary
Background
Acute respiratory failure is a common and life-threatening medical emergency. 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 face mask. 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.Aim
The purpose of this study is to see whether it is possible 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 participants 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. 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 safeguards are adhered to. Trials of emergency treatments would be impossible without this. 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. Paramedics will also be surveyed to understand their experience of 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.REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
16/YH/0406
Date of REC Opinion
31 Oct 2016
REC opinion
Further Information Favourable Opinion