None listed
Conditions
Brief summary
This randomised controlled trial (RCT) aims to compare clinical outcomes for patients with severe respiratory distress who receive continuous positive airway pressure (CPAP) in addition to usual care to those who only receive usual care in the pre-hospital setting. CPAP is a central part of treatment for patients with severe respiratory distress in the emergency department (ED) and in hospital. The evidence for the use of CPAP in the pre-hospital setting is weak and studies have measured outcomes such as in-hospital mortality that can be attributed to in-hospital care. Furthermore, there is a paucity of robust studies from pre-hospital settings that do not rely on physician or critical care specialist managed care. Robust studies are essential to demonstrate the benefit of CPAP in the pre-hospital setting before the widespread introduction of the therapy into Australian prehospital clinical practice. The study will be conducted in the Perth metropolitan area. St John Ambulance (SJA-WA) provides all road-based emergency ambulance services in WA. All emergency calls for an ambulance in WA are received by SJA-WA service operations centre located in Perth. Ambulances are staffed by paramedics with advanced life support skills. This study will use dyspnoea scores as a primary outcome. Dyspnoea (respiratory distress) is a highly distressing symptom: patients describe a sensation of air hunger or suffocation. Alleviating suffering from severe breathlessness is a top priority in the care of patients with severe respiratory distress. The American Thoracic Society stress dyspnoea can and should be measured. Dyspnoea scales have been shown to predict hospital admissions, in-hospital mortality and early readmission in acute exacerbations of COPD. As such, dyspnoea scales are an appropriate primary outcome measure for pre-hospital research in patients with respiratory distress. Any pre-hospital study that demonstrates a reduction in patient distress is likely to change ambulance practice in the same way that interventions that reduce pain would be implemented. In summary, severe respiratory distress is a medical emergency. CPAP improves outcomes in patients with severe respiratory distress in the ED and in-hospital setting but there is a paucity of information on the efficacy of CPAP initiated early in the Australian pre-hospital setting. It is incorrect to assume that interventions applied in-hospital have similar efficacy pre-hospital, due to the differences in capacity and capabilities between the two settings. Therapies shown to be efficacious in hospitals need to be evaluated in the pre-hospital setting to ensure their safety and effectiveness prior to introduction. This information is critical to establishing the evidence base underpinning this therapy prior to ambulance services incorporating CPAP as routine clinical practice.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
Age 40 plus years, transported to a metropolitan hospital by ambulance, respiratory rate > 22 breaths per minute and identified by paramedics as experiencing severe respiratory distress of non-traumatic origin which is deteriorating despite 5 minutes of appropriate therapy
Exclusion criteria
Excluded if immediate endotracheal intubation or other methods of airway control, e.g. laryngeal mask airway are required; unconscious or only responds to pain; systolic blood pressure <90mmHg; uncooperative patient; possible pneumothorax, anaphylaxis, drowning, smoke inhalation, or aspiration