Non-Invasive Ventilation in Pulmonary Edema
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.
Device: CPAP and Non Invasive Ventilation
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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 Pressure Ventilation|
- The rate of Acute Myocardial Infarction
- Rate of endotracheal intubation
- Time of recovery (i.e. duration of ventilatory assistance)
- High Dependency Unit and hospital length of stay
|Study Start Date:||July 2002|
|Study Completion Date:||May 2005|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00453947
|Ospedale San Giovanni Bosco Medicina d'Urgenza|
|Torino, Italy, 10154|
|Principal Investigator:||Giovanni Ferrari, MD||Ospedale San Giovanni Bosco ASL4 Torino Italy|