Status:

COMPLETED

CPAP Versus NPPV in ACPE

Lead Sponsor:

Ospedale S. Giovanni Bosco

Conditions:

Pulmonary Edema

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief Summary

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

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...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

July 1 2002

Trial Type :

INTERVENTIONAL

End Date :

May 1 2005

Estimated Enrollment :

80 Patients enrolled

Trial Details

Trial ID

NCT00446498

Start Date

July 1 2002

End Date

May 1 2005

Last Update

April 3 2007

Active Locations (1)

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Ospedale San Giovanni Bosco Medicina d'Urgenza

Torino, Italy, 10154