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
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Pulmonary Edema
- Sponsor
- Ospedale S. Giovanni Bosco
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- The rate of Acute Myocardial Infarction
- Status
- Completed
- Last Updated
- 19 years ago
Overview
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 (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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
The rate of Acute Myocardial Infarction
Secondary Outcomes
- Rate of endotracheal intubation
- Mortality
- Time of recovery (i.e. duration of ventilatory assistance)
- High Dependency Unit and hospital length of stay