CPAP Versus NPPV in ACPE

Pulmonary Edema Clinical Trial

Official title:

Continuous Positive Airway Pressure Versus Non-Invasive Positive Pressure Support Ventilation in Acute Cardiogenic Pulmonary Oedema: a Prospective Randomised Multicentre Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00446498
• Other study ID #: gbosco1
• Status: Completed
• Phase: Phase 4
• First received: March 12, 2007
• Last updated: April 2, 2007
• Start date: July 2002
• Est. completion date: May 2005

Study information

• Verified date: April 2007
• Source: Ospedale S. Giovanni Bosco
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pulmonary Edema

Intervention

Device:
• CPAP and Non Invasive Ventilation

Locations

Country	Name	City	State
Italy	Ospedale San Giovanni Bosco Medicina d'Urgenza	Torino

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale S. Giovanni Bosco

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intubation rate
Secondary	time of recovery
Secondary	hospital length of stay
Secondary	mortality and improvement in gas exchange