CPAP Versus NPPV in ACPE

Ospedale S. Giovanni Bosco

Status and phase

Completed

Phase 4

Conditions

Pulmonary Edema

Treatments

Device: CPAP and Non Invasive Ventilation

Study type

Interventional

Funder types

Other

Identifiers

NCT00446498

gbosco1

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.