Myocardial Infarction Clinical Trial
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
Verified date | March 2007 |
Source | Ospedale S. Giovanni Bosco |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ministry of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | May 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - rapid onset of the symptoms - severe dyspnoea at rest - respiratory rate > 30 breaths per minute - use of accessory respiratory muscles - oxygen saturation (SpO2) inferior to 90% with an inspiratory oxygen fraction of 60% via a Venturi mask - radiological findings of ACPE Exclusion Criteria: - acute ischemic heart disease (myocardial infarction, chest pain, ST elevation) - hemodynamic instability (i.e. systolic blood pressure < 90 with dopamine or dobutamine infusion = 5 mcgr/Kg/min) or life-threatening arrhythmias - need for immediate endotracheal intubation (respiratory arrest, bradypnea or gasping) - inability to protect the airways - impaired sensorium (i.e. unconsciousness or agitation) - inability to clear secretions - respiratory tract infection - recent oesophageal/gastric surgery - gastrointestinal bleeding - facial deformities - hematological malignancy or cancer with an Eastern Cooperative Oncology Group performance status = 2 - chronic respiratory failure necessitating long-term oxygen therapy - diagnosis of myocardial infarction, pulmonary embolism, pneumonia, exacerbation of chronic obstructive pulmonary disease, pneumothorax in the previous 3 months - denial or refusal of intubation - claustrophobia - inclusion in other research protocols |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | Ospedale San Giovanni Bosco Medicina d'Urgenza | Torino |
Lead Sponsor | Collaborator |
---|---|
Ospedale S. Giovanni Bosco |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The rate of Acute Myocardial Infarction | |||
Secondary | Rate of endotracheal intubation | |||
Secondary | Mortality | |||
Secondary | Time of recovery (i.e. duration of ventilatory assistance) | |||
Secondary | High Dependency Unit and hospital length of stay |
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