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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPAP + ST | Active Comparator | Continuous positive airway pressure (CPAP) and Standard medical therapy (ST) |
|
| BiPAP + ST | Active Comparator | Bilevel positive airway pressure (BiPAP) and standard medical therapy (ST) |
|
| ST | Active Comparator | Standard Medical therapy (ST) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| standard therapy (ST) | Other | standard medical therapy |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Who Were Intubated | Number of patients who were subjected to endotracheal intubation and invasive mechanical ventilation | During ICU Stay |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Hospital stay |
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Inclusion Criteria:
Exclusion Criteria:
Immediate need for endotracheal intubation:
Severe chronic renal failure
Pneumothorax.
Contraindication of non invasive ventilation (NIV)
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| Name | Affiliation | Role |
|---|---|---|
| Gamal M Agmy, MD, FCCP | Chest Department, Faculty of Medicine-Assiut University | Principal Investigator |
| 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 | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assiut University Hospital | Asyut | 71111 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12441754 | Background | Chadda K, Annane D, Hart N, Gajdos P, Raphael JC, Lofaso F. Cardiac and respiratory effects of continuous positive airway pressure and noninvasive ventilation in acute cardiac pulmonary edema. Crit Care Med. 2002 Nov;30(11):2457-61. doi: 10.1097/00003246-200211000-00009. | |
| 18614781 | Background | Gray A, Goodacre S, Newby DE, Masson M, Sampson F, Nicholl J; 3CPO Trialists. Noninvasive ventilation in acute cardiogenic pulmonary edema. N Engl J Med. 2008 Jul 10;359(2):142-51. doi: 10.1056/NEJMoa0707992. |
| Label | URL |
|---|---|
| Medscape: Free CME, Medical News, Full-text Journal Articles \& More | View source |
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All enrolled participants were assigned to one of the three studied groups.
Location: Respiratory and Coronary Intensive Care Units of Assiut University Hospital. Patients with acute cardiogenic pulmonary oedema (CPE)
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| ID | Title | Description |
|---|---|---|
| FG000 | CPAP+ST | Continuous positive airway pressure plus standard medical therapy |
| FG001 | BiPAP + ST | Bilevel positive airway pressure + standard medical therapy |
| FG002 | Standard Treatment | Standard medical therapy alone |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | CPAP+ST | Continuous positive airway pressure plus standard medical therapy |
| BG001 | BiPAP + ST | Bilevel positive airway pressure + standard medical therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | 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 | Not Posted | Jan 2010 | Hospital stay | ||||||||||||
| Primary | Number of Patients Who Were Intubated | Number of patients who were subjected to endotracheal intubation and invasive mechanical ventilation | Posted | Nov 2008 | Number | participants | During ICU Stay |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Maha K Ghanem, MD, FCCP | Chest Department, Faculty of Medicine, Assiut University- EGYPT | + 2 0127694434 | mahaghanem@hotmail.com |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| CPAP | Device | Non-invasive mechanical ventilation (CPAP) |
|
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| BIPAP | Device | Non-invasive mechanical ventilation (BIPAP) |
|
|
| 16210459 | Background | Agarwal R, Aggarwal AN, Gupta D, Jindal SK. Non-invasive ventilation in acute cardiogenic pulmonary oedema. Postgrad Med J. 2005 Oct;81(960):637-43. doi: 10.1136/pgmj.2004.031229. |
| 18646124 | Result | Vital FM, Saconato H, Ladeira MT, Sen A, Hawkes CA, Soares B, Burns KE, Atallah AN. Non-invasive positive pressure ventilation (CPAP or bilevel NPPV) for cardiogenic pulmonary edema. Cochrane Database Syst Rev. 2008 Jul 16;(3):CD005351. doi: 10.1002/14651858.CD005351.pub2. |
| U.S. National Library of Medicine \& the National Institutes of Health | View source |
| The Cochrane library: Evidence for healthcare decision-making | View source |
| BG002 | Standard Treatment | Standard medical therapy alone |
| BG003 | Total | Total of all reporting groups |
| Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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