Pulmonary Edema Clinical Trial
Official title:
Continuous Positive Airway Pressure Versus Non-Invasive Positive Pressure Support Ventilation in Acute Cardiogenic Pulmonary Oedema: a Prospective Randomised Multicentre Trial.
Verified date | April 2007 |
Source | Ospedale S. Giovanni Bosco |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ministry of Health |
Study type | Interventional |
To assess the intubation rate in patients affected by severe cardiogenic pulmonary edema treated with CPAP or NPPV.
Status | Completed |
Enrollment | 80 |
Est. completion date | May 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - rapid onset of the symptoms - severe dyspnoea at rest - respiratory rate > 30 breath per minute - use of accessory respiratory muscles - PaO2/FiO2 < 200, radiological findings of ACPE Exclusion Criteria: - ST elevation myocardial infarction - hemodynamic instability (systolic arterial pressure < 90 mmHg - need for immediate endotracheal intubation (respiratory arrest, bradypnea - inability to protect the airways, impaired sensorium (agitation or unconsciousness - inability to clear secretions, respiratory tract infections - chronic obstructive pulmonary disease (COPD) exacerbation, chronic respiratory failure necessitating long-term oxygen therapy - pulmonary embolism, pneumonia, recent oesophageal-gastric surgery - gastrointestinal bleeding - facial deformities - haematological malignancy or cancer with Eastern Cooperative Oncology Group (ECOG) performance status = 2. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | Ospedale San Giovanni Bosco Medicina d'Urgenza | Torino |
Lead Sponsor | Collaborator |
---|---|
Ospedale S. Giovanni Bosco |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intubation rate | |||
Secondary | time of recovery | |||
Secondary | hospital length of stay | |||
Secondary | mortality and improvement in gas exchange |
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