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Sponsored by: |
Ospedale S. Giovanni Bosco |
Information provided by: | Ospedale S. Giovanni Bosco |
ClinicalTrials.gov Identifier: | NCT00453947 |
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.
Condition | Intervention | Phase |
Pulmonary Edema Myocardial Infarction |
Device: CPAP and Non Invasive Ventilation |
Phase IV |
MedlinePlus related topics: | Edema Heart Attack |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study |
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 |
Estimated Enrollment: | 60 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Italy | |||||
Ospedale San Giovanni Bosco Medicina d'Urgenza | |||||
Torino, Italy, 10154 |
Ospedale S. Giovanni Bosco |
Principal Investigator: | Giovanni Ferrari, MD | Ospedale San Giovanni Bosco ASL4 Torino Italy |
Study ID Numbers: | gbosco2 |
First Received: | March 28, 2007 |
Last Updated: | March 28, 2007 |
ClinicalTrials.gov Identifier: | NCT00453947 |
Health Authority: | Italy: Ministry of Health |
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