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CPAP Versus NPPV in ACPE

This study has been completed.
Sponsor:
Information provided by:
Ospedale S. Giovanni Bosco
ClinicalTrials.gov Identifier:
NCT00446498
First received: March 12, 2007
Last updated: April 2, 2007
Last verified: April 2007
History of Changes
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:

MedlinePlus related topics: Edema
U.S. FDA Resources

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

Primary Outcome Measures:
  • Intubation rate

Secondary Outcome Measures:
  • time of recovery
  • hospital length of stay
  • mortality and improvement in gas exchange

Estimated Enrollment: 80
Study Start Date: July 2002
Study Completion Date: May 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00446498

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

No publications provided

ClinicalTrials.gov Identifier: NCT00446498     History of Changes
Other Study ID Numbers: gbosco1
Study First Received: March 12, 2007
Last Updated: April 2, 2007
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Edema
Pulmonary Edema
Signs and Symptoms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 18, 2013