Myocardial Infarction, Pulmonary Edema
Conditions
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.
Interventions
Sponsors
Ospedale S. Giovanni Bosco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of Acute Myocardial Infarction | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of endotracheal intubation | — |
| Mortality | — |
| Time of recovery (i.e. duration of ventilatory assistance) | — |
| High Dependency Unit and hospital length of stay | — |
Countries
Italy
Outcome results
None listed