Clinical Trial: Non-Invasive Ventilation in Pulmonary Edema
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Non Invasive Positive Airway Pressure And Risk Of Myocardial Infarction In Acute Cardiogenic Pulmonary Edema: Continuous Positive Airway Pressure Vs Non Invasive Positive
Brief Summary: This randomized controlled trial is primarily aimed at assessing the rate of acute myocardial infarction with the two noninvasive ventilatory techniques, non-invasive intermittent positive pressure ventilation and non-invasive continuous positive airway pressure.
Detailed Summary:
Objective: To determine whether the application of non-invasive intermittent positive pressure ventilation (n-IPPV) increases the incidence of acute myocardial infarction (AMI) in patients with acute respiratory failure (ARF) secondary to acute cardiogenic pulmonary edema (ACPE), as opposed to non-invasive continuous positive airway pressure (n-CPAP).
Background Both n-CPAP or n-IPPV are used to treat ACPE complicated by ARF. Two previous studies, however, report an increased rate of AMI associated with the use of n-IPPV.
Methods: Fifty-two patients with severe ARF consequent to ACPE were randomized to receive n-CPAP (n=27) or n-IPPV (n=25), both associated with standard medical therapy. Cardiac markers, electrocardiogram and clinical-physiological parameters were monitored at study entry, after 30 and 60 minutes, and every 6 hours for the first two days.
Sponsor: Ospedale S. Giovanni Bosco
Current Primary Outcome: The rate of Acute Myocardial Infarction
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Rate of endotracheal intubation
- Mortality
- Time of recovery (i.e. duration of ventilatory assistance)
- High Dependency Unit and hospital length of stay
Original Secondary Outcome: Same as current
Information By: Ospedale S. Giovanni Bosco
Dates:
Date Received: March 28, 2007
Date Started: July 2002
Date Completion:
Last Updated: March 28, 2007
Last Verified: March 2007
