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CPAP Versus NPPV in ACPE

Primary Purpose

Pulmonary Edema

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
CPAP and Non Invasive Ventilation
Sponsored by
Ospedale S. Giovanni Bosco
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Edema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Ospedale San Giovanni Bosco Medicina d'Urgenza

Outcomes

Primary Outcome Measures

Intubation rate

Secondary Outcome Measures

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

Full Information

First Posted
March 12, 2007
Last Updated
April 2, 2007
Sponsor
Ospedale S. Giovanni Bosco
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1. Study Identification

Unique Protocol Identification Number
NCT00446498
Brief Title
CPAP Versus NPPV in ACPE
Official Title
Continuous Positive Airway Pressure Versus Non-Invasive Positive Pressure Support Ventilation in Acute Cardiogenic Pulmonary Oedema: a Prospective Randomised Multicentre Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ospedale S. Giovanni Bosco

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Edema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
CPAP and Non Invasive Ventilation
Primary Outcome Measure Information:
Title
Intubation rate
Secondary Outcome Measure Information:
Title
time of recovery
Title
hospital length of stay
Title
mortality and improvement in gas exchange

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giovanni Ferrari, MD
Organizational Affiliation
Ospedale San Giovanni Bosco ASL4
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Giovanni Ferrari, MD
Organizational Affiliation
Ospedale San Giovanni Bosco ASL4 Torino Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedale San Giovanni Bosco Medicina d'Urgenza
City
Torino
ZIP/Postal Code
10154
Country
Italy

12. IPD Sharing Statement

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CPAP Versus NPPV in ACPE

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