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Continuous Positive Airway Pressure (CPAP) for the treatment of severe respiratory distress in the pre-hospital setting

Continuous Positive Airway Pressure (CPAP) trial for the treatment of severe respiratory distress by ambulance paramedics in the pre-hospital setting.

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615001180505
Enrollment
708
Registered
2015-11-03
Start date
2016-03-03
Completion date
2018-12-31
Last updated
2022-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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

Continuous Positive Airway Pressure (CPAP) and usual care. CPAP will be delivered continuously by a CPAP facial mask, set at 10cm H2o by ambulance paramedics. CPAP will be delivered by the paramedic from identification of severe respiratory distress until arrival at the hospital. Usual care is the care routinely administered by paramedics for severe respiratory distress that is guided by the ambulance Clinical Practice Guidelines.

Sponsors

Curtin University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
40 Years to No maximum
Healthy volunteers
No

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 15, 2026