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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00912158 |
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Date of registration:
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08/04/2009 |
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Primary sponsor: |
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Public title:
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Non Invasive Mechanical Ventilation in Acute Cardiogenic Pulmonary Edema
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Scientific title:
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CPAP Versus BiPAP in Acute Cardiogenic Pulmonary Edema: Experience With 129 Patients |
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Date of first enrolment:
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October 2003 |
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Target sample size:
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129 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00912158 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Egypt
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Contacts
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Name:
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Hatem A Helmy, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Cardiology Department, Faculty of Medicine - Assiut University |
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Name:
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Hamdy S Mohamed, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Cardiology Department, Faculty of Medicine- Assiut University |
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Name:
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Amany O Mohamed, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Chest Department, Faculty of Medicine- Assiut University |
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Name:
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Hoda A Makhlouf, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Chest Department, Faculty of Medicine- Assiut University |
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Name:
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Maha K Ghanem, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Chest Department, Faculty of Medicine- Assiut University |
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Name:
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Gamal M Agmy, MD, FCCP |
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Address:
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Telephone:
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Email:
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Affiliation:
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Chest Department, Faculty of Medicine-Assiut University |
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Key inclusion & exclusion criteria
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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)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Acute Cardiogenic Pulmonary Edema
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Intervention(s)
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Device: BIPAP
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Device: CPAP
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Other: standard therapy (ST)
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Primary Outcome(s)
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Number of Patients Who Were Intubated
[Time Frame: During ICU Stay]
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Secondary Outcome(s)
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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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Secondary ID(s)
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RICU, Assiut University 1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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