Non-Invasive Ventilation in Pulmonary Edema
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|ClinicalTrials.gov Identifier: NCT00453947|
Recruitment Status : Completed
First Posted : March 29, 2007
Last Update Posted : March 29, 2007
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Edema Myocardial Infarction||Device: CPAP and Non Invasive Ventilation||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||July 2002|
|Actual Study Completion Date :||May 2005|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00453947
|Ospedale San Giovanni Bosco Medicina d'Urgenza|
|Torino, Italy, 10154|
|Principal Investigator:||Giovanni Ferrari, MD||Ospedale San Giovanni Bosco ASL4 Torino Italy|