CPAP Versus NPPV in ACPE - Full Text View

Sponsored by:	Ospedale S. Giovanni Bosco
Information provided by:	Ospedale S. Giovanni Bosco
ClinicalTrials.gov Identifier:	NCT00446498

Purpose

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

Condition	Intervention	Phase
Pulmonary Edema	Device: CPAP and Non Invasive Ventilation	Phase IV

MedlinePlus related topics: Edema

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Continuous Positive Airway Pressure Versus Non-Invasive Positive Pressure Support Ventilation in Acute Cardiogenic Pulmonary Oedema: a Prospective Randomised Multicentre Trial.

Further study details as provided by Ospedale S. Giovanni Bosco:

Primary Outcome Measures:

Intubation rate

Secondary Outcome Measures:

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

Estimated Enrollment:	80
Study Start Date:	July 2002
Study Completion Date:	May 2005

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00446498

Locations

Italy
Ospedale San Giovanni Bosco Medicina d'Urgenza
Torino, Italy, 10154

Sponsors and Collaborators

Ospedale S. Giovanni Bosco

Investigators

Principal Investigator:	Giovanni Ferrari, MD	Ospedale San Giovanni Bosco ASL4
Principal Investigator:	Giovanni Ferrari, MD	Ospedale San Giovanni Bosco ASL4 Torino Italy

More Information

Study ID Numbers:	gbosco1
Study First Received:	March 12, 2007
Last Updated:	April 2, 2007
ClinicalTrials.gov Identifier:	NCT00446498
Health Authority:	Italy: Ministry of Health

Study placed in the following topic categories:

Signs and Symptoms
Pulmonary Edema
Respiratory Tract Diseases
Lung Diseases
Edema

ClinicalTrials.gov processed this record on January 16, 2009