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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00446498

Enrollment

Registered

2007-03-13

Start date

2002-07-31

Completion date

2005-05-31

Last updated

2007-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Edema

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 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.

Interventions

DEVICECPAP and Non Invasive Ventilation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Intubation rate	—

Secondary

Measure	Time frame
time of recovery	—
hospital length of stay	—
mortality and improvement in gas exchange	—

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026