None listed
Conditions
Brief summary
Continous postitive airway pressure (CPAP) is a proven therapy when administered in the emergency department. The evidence supporting it's use in the preshospital setting is not definitive and consisits of surrogate outcome measures hence this trial, powered to detect a difference in the true outcome of mortality, should provide important evidence. Our hypothesis is that adding continous positive airway pressure to standard care in the prehospial setting will decrease hospital mortality comparted to standard care alone.
Interventions
Standard prehospital care plus continuous positive airway pressure (CPAP).
Standard care consists of sublingual glyceral trinitrate, intravenous frusemide, intranvenous morphine, and nebulised salbutamol. Patients may receive any combination of the above on a case by case basis. In addition the intervention group will receive continuous postitive airway pressure using the Boussignac CPAP device at a therapeutic level of 10cm H2O positive end expiratory pressure, a therapeutic goods association
Standard prehospital care plus continuous positive airway pressure (CPAP). Standard care consists of sublingual glyceral trinitrate, intravenous frusemide, intranvenous morphine, and nebulised salbutamol. Patients may receive any combination of the above on a case by case basis. In addition the intervention group will receive continuous postitive airway pressure using the Boussignac CPAP device at a therapeutic level of 10cm H2O positive end expiratory pressure, a therapeutic goods association (TGA) approved lightweight and portable CPAP system. Patients randomised to this intervention group will begin receiving CPAP on scene administered by the paramedics. CPAP will be continuously administered until arrvial at the emergency department or until the patient's clinical condition warrants cessation of the CPAP therapy
Sponsors
Ambulance Research Institute, Ambulance Service of New South Wales
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion criteria: i. aged greater than or equal to 18 years ii. conscious (Glasgow Coma Scale (GCS)=15) iii. presumed diagnosis of acute cardiogenic pulmonary oedema with: a) increased work of breathing/accessory muscle use b) hypoxic with oxygen saturation less than 92% c) bilateral basal crackles on chest auscultation d) respiratory rate greater than or equal to 28
Exclusion criteria
i. inadequate ventilatory effort requiring ventilatory assistance (ie. hypoventilation requiring intermittent positive pressure ventilation (IPPV)) ii. systolic blood pressure less than 100 mmHg iii. suspected acute myocardial infarction
Outcome results
None listed