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Non Invasive Mechanical Ventilation in Acute Cardiogenic Pulmonary Edema

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ClinicalTrials.gov Identifier: NCT00912158
Recruitment Status : Completed
First Posted : June 3, 2009
Results First Posted : June 3, 2009
Last Update Posted : September 4, 2009
Sponsor:
Information provided by:
Assiut University

Brief Summary:
Cardiogenic pulmonary edema (CPE) is a common medical emergency and noninvasive ventilation (NIV) in addition to conventional medical treatment might be beneficial for patients with CPE.

Condition or disease Intervention/treatment Phase
Acute Cardiogenic Pulmonary Edema Other: standard therapy (ST) Device: CPAP Device: BIPAP Phase 4

Detailed Description:
To evaluate the effect of adding continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP) to standard medical therapy (ST) on intensive care unit (ICU) stay, hospital stay, mortality, need for endotracheal intubation, partial arterial O2 tension (PaO2), intrapulmonary shunt, alveolar-arterial (A-a) oxygen gradient, and cardiac output in patients admitted to the respiratory intensive care unit (ICU) or cardiac care unit (CCU) with acute CPE with gas exchange abnormalities and to evaluate the impact of heart failure type on the outcome of different therapeutic schedules.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CPAP Versus BiPAP in Acute Cardiogenic Pulmonary Edema: Experience With 129 Patients
Study Start Date : October 2003
Primary Completion Date : November 2007
Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: CPAP + ST
Continuous positive airway pressure (CPAP) and Standard medical therapy (ST)
Device: CPAP
Non-invasive mechanical ventilation (CPAP)
Other Names:
  • Continuous postive air way pressure
  • noninvasive positive support ventilation (NPSV)
Active Comparator: BiPAP + ST
Bilevel positive airway pressure (BiPAP) and standard medical therapy (ST)
Device: BIPAP
Non-invasive mechanical ventilation (BIPAP)
Other Name: Bilevel Positive Airway Pressure ventilation
Active Comparator: ST
Standard Medical therapy (ST)
Other: standard therapy (ST)
standard medical therapy
Other Name: Medical treatment of acute cardiogenic pulmonary oedema



Primary Outcome Measures :
  1. Number of Patients Who Were Intubated [ Time Frame: During ICU Stay ]

Secondary Outcome Measures :
  1. Arterial Blood Gases, Respiratory Rate, Blood Pressure, Cardiac Output ,Intrapulmonary Shunt, A-a Oxygen Gradient, Heart Rate, and Dyspnea Duration of Hospital and ICU Stay and Mortality [ Time Frame: Hospital stay ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. CPE confirmed radiologically and/or clinically
  2. Severe acute respiratory failure (partial arterial oxygen (PaO2)/Fraction of inspired oxygen (FIO2) less than 250)
  3. Dyspnea of sudden onset with respiratory
  4. Systolic blood pressure < 180 mmHg

Exclusion Criteria:

  1. Immediate need for endotracheal intubation:

    • Severe sensorial impairment
    • Shock
    • Ventricular arrhythmias,
    • Life-threatening hypoxia (SpO2 [oxygen saturation as indicated by pulse oximetry] less than 80% with oxygen)
    • Acute myocardial infarction necessitating thrombolysis
    • Cardiac or respiratory arrest
  2. Severe chronic renal failure
  3. Pneumothorax.
  4. Contraindication of non invasive ventilation (NIV)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00912158


Locations
Egypt
Assiut University Hospital
Assiut, Egypt, 71111
Sponsors and Collaborators
Assiut University
Investigators
Principal Investigator: Gamal M Agmy, MD, FCCP Chest Department, Faculty of Medicine-Assiut University
Study Chair: Maha K Ghanem, MD Chest Department, Faculty of Medicine- Assiut University
Study Chair: Hoda A Makhlouf, MD Chest Department, Faculty of Medicine- Assiut University
Study Chair: Amany O Mohamed, MD Chest Department, Faculty of Medicine- Assiut University
Study Chair: Hamdy S Mohamed, MD Cardiology Department, Faculty of Medicine- Assiut University
Study Chair: Hatem A Helmy, MD Cardiology Department, Faculty of Medicine - Assiut University

Additional Information:
Publications:
Responsible Party: Prof. Gamal R Agmy, Faculty of Medicine, Assiut University
ClinicalTrials.gov Identifier: NCT00912158     History of Changes
Other Study ID Numbers: RICU, Assiut University 1
First Posted: June 3, 2009    Key Record Dates
Results First Posted: June 3, 2009
Last Update Posted: September 4, 2009
Last Verified: August 2009

Keywords provided by Assiut University:
CPE
CPAP
BiPAP
non invasive mechanical ventilation

Additional relevant MeSH terms:
Edema
Pulmonary Edema
Signs and Symptoms
Lung Diseases
Respiratory Tract Diseases