Status:
COMPLETED
Non-Invasive Ventilation in Pulmonary Edema
Lead Sponsor:
Ospedale S. Giovanni Bosco
Conditions:
Pulmonary Edema
Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ve...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
End Date :
May 1 2005
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00453947
Start Date
July 1 2002
End Date
May 1 2005
Last Update
March 29 2007
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Ospedale San Giovanni Bosco Medicina d'Urgenza
Torino, Torino, Italy, 10154