NCT00446498

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2002

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

March 12, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 13, 2007

Completed
Last Updated

April 3, 2007

Status Verified

April 1, 2007

First QC Date

March 12, 2007

Last Update Submit

April 2, 2007

Conditions

Pulmonary Edema

Outcome Measures

Primary Outcomes (1)

  • Intubation rate

Secondary Outcomes (3)

  • time of recovery

  • hospital length of stay

  • mortality and improvement in gas exchange

Interventions

CPAP and Non Invasive VentilationDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale San Giovanni Bosco Medicina d'Urgenza

Torino, 10154, Italy

Location

MeSH Terms

Conditions

Pulmonary Edema

Interventions

Continuous Positive Airway PressureNoninvasive Ventilation

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Giovanni Ferrari, MD

    Ospedale San Giovanni Bosco ASL4

    PRINCIPAL INVESTIGATOR

  • Giovanni Ferrari, MD

    Ospedale San Giovanni Bosco ASL4 Torino Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 12, 2007

First Posted

March 13, 2007

Study Start

July 1, 2002

Study Completion

May 1, 2005

Last Updated

April 3, 2007

Record last verified: 2007-04

Locations

IT(1)