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CPAP Versus Bilevel Pressure Support Ventilation in Cardiogenic Pulmonary Edema

Primary Purpose

Severe Acute Cardiogenic Pulmonary Edema

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Boussignac CPAP - bilevel ventilation support
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Acute Cardiogenic Pulmonary Edema focused on measuring Pulmonary edema, respiratory failure, pressure support ventilation, continuous positive pressure

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: age > 16 yrs, acute onset of severe respiratory distress, bilateral rales and typical findings of congestion on chest radiograph breathing frequency of > 30/min, SpO2 >90%, use of accessory respiratory muscles

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Improvement in PaCO2 at the end of ventilation

    Secondary Outcome Measures

    Endotracheal intubation, myocardial infarction and mortality during the first 24 hours
    Duration of the ventilation
    Blood gases, vital signs
    Time to transfer to medical ward
    Time to hospital discharge
    Easiness to use was evaluated by nurses
    Patients operational tolerance
    Complications of each ventilation mode

    Full Information

    First Posted
    September 14, 2005
    Last Updated
    June 17, 2013
    Sponsor
    University Hospital, Rouen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00213681
    Brief Title
    CPAP Versus Bilevel Pressure Support Ventilation in Cardiogenic Pulmonary Edema
    Official Title
    CPAP Boussignac Versus Bilevel Pressure Support Ventilation in Severe Acute Cardiogenic Pulmonary Edema
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2002 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    March 2005 (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Rouen

    4. Oversight

    5. Study Description

    Brief Summary
    To evaluate whether bilevel positive airway pressure more rapidly improves ventilation than continuous positive airway pressure (CPAP) in patients with acute pulmonary edema. CPAP is delivered via a simple device connected to oxygen.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Severe Acute Cardiogenic Pulmonary Edema
    Keywords
    Pulmonary edema, respiratory failure, pressure support ventilation, continuous positive pressure

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Device
    Intervention Name(s)
    Boussignac CPAP - bilevel ventilation support
    Primary Outcome Measure Information:
    Title
    Improvement in PaCO2 at the end of ventilation
    Secondary Outcome Measure Information:
    Title
    Endotracheal intubation, myocardial infarction and mortality during the first 24 hours
    Title
    Duration of the ventilation
    Title
    Blood gases, vital signs
    Title
    Time to transfer to medical ward
    Title
    Time to hospital discharge
    Title
    Easiness to use was evaluated by nurses
    Title
    Patients operational tolerance
    Title
    Complications of each ventilation mode

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: age > 16 yrs, acute onset of severe respiratory distress, bilateral rales and typical findings of congestion on chest radiograph breathing frequency of > 30/min, SpO2 >90%, use of accessory respiratory muscles
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Fabienne MORITZ, MD
    Organizational Affiliation
    University Hospital, Rouen
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    CPAP Versus Bilevel Pressure Support Ventilation in Cardiogenic Pulmonary Edema

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