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
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jul 2002
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
March 28, 2007
CompletedFirst Posted
Study publicly available on registry
March 29, 2007
CompletedMarch 29, 2007
March 1, 2007
March 28, 2007
March 28, 2007
Conditions
Outcome Measures
Primary Outcomes (1)
The rate of Acute Myocardial Infarction
Secondary Outcomes (4)
Rate of endotracheal intubation
Mortality
Time of recovery (i.e. duration of ventilatory assistance)
High Dependency Unit and hospital length of stay
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ospedale San Giovanni Bosco Medicina d'Urgenza
Torino, Torino, 10154, Italy
Related Publications (1)
Ferrari G, Olliveri F, De Filippi G, Milan A, Apra F, Boccuzzi A, Converso M, Navalesi P. Noninvasive positive airway pressure and risk of myocardial infarction in acute cardiogenic pulmonary edema: continuous positive airway pressure vs noninvasive positive pressure ventilation. Chest. 2007 Dec;132(6):1804-9. doi: 10.1378/chest.07-1058. Epub 2007 Oct 1.
PMID: 17908705DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Giovanni Ferrari, MD
Ospedale San Giovanni Bosco ASL4 Torino Italy
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 28, 2007
First Posted
March 29, 2007
Study Start
July 1, 2002
Study Completion
May 1, 2005
Last Updated
March 29, 2007
Record last verified: 2007-03