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Completed

NCT Number: NCT00446498

CPAP Versus NPPV in ACPE

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

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Key information

Conditions

Pulmonary Edema Lung Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ospedale San Giovanni Bosco Medicina d'Urgenza

Torino, 10154, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CPAP and Non Invasive Ventilation

Device

Primary outcomes

  1. Intubation rate

Secondary outcomes

  1. time of recovery

  2. hospital length of stay

  3. mortality and improvement in gas exchange

Sponsors and collaborators

Lead sponsor

Ospedale S. Giovanni Bosco

Other

Registry information

Official study title

Continuous Positive Airway Pressure Versus Non-Invasive Positive Pressure Support Ventilation in Acute Cardiogenic Pulmonary Oedema: a Prospective Randomised Multicentre Trial.

Important dates

Study start
2002
Study completion
2005
First posted
Mar 13, 2007
Registry last updated
Apr 3, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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