The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00446498
Recruitment Status : Completed
First Posted : March 13, 2007
Last Update Posted : April 3, 2007
Information provided by:
Ospedale S. Giovanni Bosco

Brief Summary:
To assess the intubation rate in patients affected by severe cardiogenic pulmonary edema treated with CPAP or NPPV.

Condition or disease Intervention/treatment Phase
Pulmonary Edema Device: CPAP and Non Invasive Ventilation Phase 4

Detailed Description:

Background Although non-invasive ventilation has shown to be an effective treatment for acute cardiogenic pulmonary oedema (ACPO), literature still lacks of multi-centre randomised prospective studies that compares CPAP with NPPV.

Aim of the study was to assess efficacy and safety of CPAP and NPPV in patients with ACPO.

Methods 80 patients with ACPO were randomly assigned to receive CPAP or NPPV (40 for each group) through a face mask.

Inclusion criteria were: severe dyspnoea, respiratory rate > 30, PaO2/FiO2 < 200, muscle fatigue.

Main end-points were endotracheal intubation, length of ventilation, hospital length of stay and mortality.

Study Type : Interventional  (Clinical Trial)
Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Continuous Positive Airway Pressure Versus Non-Invasive Positive Pressure Support Ventilation in Acute Cardiogenic Pulmonary Oedema: a Prospective Randomised Multicentre Trial.
Study Start Date : July 2002
Actual Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
U.S. FDA Resources

Primary Outcome Measures :
  1. Intubation rate

Secondary Outcome Measures :
  1. time of recovery
  2. hospital length of stay
  3. mortality and improvement in gas exchange

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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 breath per minute
  • use of accessory respiratory muscles
  • PaO2/FiO2 < 200, radiological findings of ACPE

Exclusion Criteria:

  • ST elevation myocardial infarction
  • hemodynamic instability (systolic arterial pressure < 90 mmHg
  • need for immediate endotracheal intubation (respiratory arrest, bradypnea
  • inability to protect the airways, impaired sensorium (agitation or unconsciousness
  • inability to clear secretions, respiratory tract infections
  • chronic obstructive pulmonary disease (COPD) exacerbation, chronic respiratory failure necessitating long-term oxygen therapy
  • pulmonary embolism, pneumonia, recent oesophageal-gastric surgery
  • gastrointestinal bleeding
  • facial deformities
  • haematological malignancy or cancer with Eastern Cooperative Oncology Group (ECOG) performance status ≥ 2.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00446498

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
Principal Investigator: Giovanni Ferrari, MD Ospedale San Giovanni Bosco ASL4 Torino Italy Identifier: NCT00446498     History of Changes
Other Study ID Numbers: gbosco1
First Posted: March 13, 2007    Key Record Dates
Last Update Posted: April 3, 2007
Last Verified: April 2007

Additional relevant MeSH terms:
Pulmonary Edema
Lung Diseases
Respiratory Tract Diseases