Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00453947
Status:
COMPLETED
Last Update Posted:
2007-03-29
First Post:
2007-03-28
Brief Title:
Non-Invasive Ventilation in Pulmonary Edema
Sponsor:
Ospedale S Giovanni Bosco
Organization:
Ospedale S Giovanni Bosco
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2007-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Description:
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 n27 or n-IPPV n25 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
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 n27 or n-IPPV n25 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None