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Non-Invasive Ventilation in Pulmonary Edema

This study has been completed.
Information provided by:
Ospedale S. Giovanni Bosco Identifier:
First received: March 28, 2007
Last updated: NA
Last verified: March 2007
History: No changes posted
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.

Condition Intervention Phase
Pulmonary Edema Myocardial Infarction Device: CPAP and Non Invasive Ventilation Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Ospedale S. Giovanni Bosco:

Primary Outcome Measures:
  • The rate of Acute Myocardial Infarction

Secondary Outcome Measures:
  • Rate of endotracheal intubation
  • Mortality
  • Time of recovery (i.e. duration of ventilatory assistance)
  • High Dependency Unit and hospital length of stay

Estimated Enrollment: 60
Study Start Date: July 2002
Study Completion Date: May 2005
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
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Please refer to this study by its identifier: NCT00453947

Ospedale San Giovanni Bosco Medicina d'Urgenza
Torino, Italy, 10154
Sponsors and Collaborators
Ospedale S. Giovanni Bosco
Principal Investigator: Giovanni Ferrari, MD Ospedale San Giovanni Bosco ASL4 Torino Italy
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00453947     History of Changes
Other Study ID Numbers: gbosco2
Study First Received: March 28, 2007
Last Updated: March 28, 2007

Additional relevant MeSH terms:
Myocardial Infarction
Pulmonary Edema
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Signs and Symptoms
Lung Diseases
Respiratory Tract Diseases processed this record on August 18, 2017