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CompletedNCT00446498Updated Apr 3, 2007

CPAP Versus NPPV in ACPE

A Phase 4 interventional study of CPAP and Non Invasive Ventilation in Pulmonary Edema, sponsored by Ospedale S. Giovanni Bosco. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-04-03.

Sponsored by Ospedale S. Giovanni Bosco · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Pulmonary Edema

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03

In context

Pulmonary Edema

138 studies on the registry are indexed under Pulmonary Edema; 24 are open to participants now.

This study's enrollment of 80 is above the median of 68 across 72 interventional studies indexed under Pulmonary Edema.

Browse Pulmonary Edema studies →

Lead sponsor

Ospedale S. Giovanni Bosco is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants

Interventions

  • DeviceCPAP and Non Invasive Ventilation
06

What researchers measure

Primary outcomes

  1. Intubation rate

Secondary outcomes

  1. time of recovery

  2. hospital length of stay

  3. mortality and improvement in gas exchange

07

Study locations

1 site
  • Ospedale San Giovanni Bosco Medicina d'Urgenza
    Torino, 10154, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 3, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00446498
Lead sponsor
Ospedale S. Giovanni Bosco
First posted
Mar 13, 2007
Start date
Jul 2002
Completion
May 2005
Last update
Apr 3, 2007

Study contacts

Giovanni Ferrari, MD
principal investigator · Ospedale San Giovanni Bosco ASL4
Giovanni Ferrari, MD
principal investigator · Ospedale San Giovanni Bosco ASL4 Torino Italy
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2007. You cannot join it, but the record below documents what was studied.

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