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Non Invasive Mechanical Ventilation in Acute Cardiogenic Pulmonary Edema

This study has been completed.
Sponsor:
Information provided by:
Assiut University
ClinicalTrials.gov Identifier:
NCT00912158
First received: April 8, 2009
Last updated: August 17, 2009
Last verified: August 2009
History of Changes
  Purpose

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 Intervention Phase
Acute Cardiogenic Pulmonary Edema
 Other: standard therapy (ST)
Device: CPAP
Device: BIPAP
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CPAP Versus BiPAP in Acute Cardiogenic Pulmonary Edema: Experience With 129 Patients

Resource links provided by NLM:

MedlinePlus related topics: Edema
U.S. FDA Resources

Further study details as provided by Assiut University:

Primary Outcome Measures:
  • Number of Patients Who Were Intubated [ Time Frame: During ICU Stay ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 129
Study Start Date: October 2003
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
Medscape: Free CME, Medical News, Full-text Journal Articles & More  This link exits the ClinicalTrials.gov site
U.S. National Library of Medicine & the National Institutes of Health  This link exits the ClinicalTrials.gov site
The Cochrane library: Evidence for healthcare decision-making  This link exits the ClinicalTrials.gov site

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
Study First Received: April 8, 2009
Results First Received: April 8, 2009
Last Updated: August 17, 2009
Health Authority: Egypt: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 19, 2013