CPAP Versus NPPV in ACPE

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

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

Study Overview

• Status: Completed
• Conditions: Pulmonary Edema
• Intervention / Treatment: Device: CPAP and Non Invasive Ventilation

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
• Enrollment: 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Torino, Italy, 10154
    • Ospedale San Giovanni Bosco Medicina d'Urgenza

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Intubation rate

Secondary Outcome Measures

Outcome Measure
time of recovery
hospital length of stay
mortality and improvement in gas exchange

Collaborators and Investigators

• Sponsor: Ospedale S. Giovanni Bosco
• Investigators: Principal Investigator: Giovanni Ferrari, MD, ospedale San Giovanni Bosco ASL4

Study record dates

Study Major Dates

• Study Start: July 1, 2002
• Study Completion (ACTUAL): May 1, 2005

Study Registration Dates

• First Submitted: March 12, 2007
• First Submitted That Met QC Criteria: March 12, 2007
• First Posted (ESTIMATE): March 13, 2007

Study Record Updates

• Last Update Posted (ESTIMATE): April 3, 2007
• Last Update Submitted That Met QC Criteria: April 2, 2007
• Last Verified: April 1, 2007

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pulmonary Edema
• Other Study ID Numbers: gbosco1