- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00453947
Non-Invasive Ventilation in Pulmonary Edema
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment
Phase
- Phase 4
Contacts and Locations
Study Locations
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Torino, Italy, 10154
- Ospedale San Giovanni Bosco Medicina d'Urgenza
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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The rate of Acute Myocardial Infarction
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Secondary Outcome Measures
Outcome Measure |
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Mortality
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Rate of endotracheal intubation
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Time of recovery (i.e. duration of ventilatory assistance)
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High Dependency Unit and hospital length of stay
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- gbosco2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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