CPAP Versus NPPV in ACPE

Ospedale S. Giovanni Bosco80 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pulmonary Edema

Interventions

CPAP and Non Invasive VentilationDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Ospedale San Giovanni Bosco Medicina d'Urgenza

Torino, Italy

Outcomes

Primary Outcomes

Intubation rate

Secondary Outcomes

time of recovery

hospital length of stay

mortality and improvement in gas exchange

Data from ClinicalTrials.gov

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