Acute Cardiogenic Pulmonary Edema
Conditions
Keywords
CPE, CPAP, BiPAP, non invasive mechanical ventilation
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.
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.
Interventions
OTHERstandard therapy (ST)
standard medical therapy
DEVICECPAP
Non-invasive mechanical ventilation (CPAP)
DEVICEBIPAP
Non-invasive mechanical ventilation (BIPAP)
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Who Were Intubated | During ICU Stay | Number of patients who were subjected to endotracheal intubation and invasive mechanical ventilation |
Secondary
| Measure | 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 |
Countries
Egypt
Participant flow
Recruitment details
Location: Respiratory and Coronary Intensive Care Units of Assiut University Hospital. Patients with acute cardiogenic pulmonary oedema (CPE)
Pre-assignment details
All enrolled participants were assigned to one of the three studied groups.
Participants by arm
| Arm | Count |
|---|---|
| CPAP+ST Continuous positive airway pressure plus standard medical therapy | 44 |
| BiPAP + ST Bilevel positive airway pressure + standard medical therapy | 44 |
| Standard Treatment Standard medical therapy alone | 41 |
| Total | 129 |
Baseline characteristics
| Characteristic | BiPAP + ST | Standard Treatment | CPAP+ST | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 32 Participants | 31 Participants | 30 Participants | 93 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 10 Participants | 14 Participants | 36 Participants |
| Age Continuous | 68 years STANDARD_DEVIATION 3.8 | 69 years STANDARD_DEVIATION 5.8 | 66 years STANDARD_DEVIATION 6.9 | 67 years STANDARD_DEVIATION 4.8 |
| Region of Enrollment Egypt | 44 participants | 41 participants | 44 participants | 129 participants |
| Sex: Female, Male Female | 12 Participants | 10 Participants | 14 Participants | 36 Participants |
| Sex: Female, Male Male | 32 Participants | 31 Participants | 30 Participants | 93 Participants |
Outcome results
Primary
Number of Patients Who Were Intubated
Number of patients who were subjected to endotracheal intubation and invasive mechanical ventilation
Time frame: During ICU Stay
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CPAP+ST | Number of Patients Who Were Intubated | 5 participants |
| BiPAP + ST | Number of Patients Who Were Intubated | 4 participants |
| Standard Treatment | Number of Patients Who Were Intubated | 10 participants |
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
Time frame: Hospital stay