Non Invasive Mechanical Ventilation in Acute Cardiogenic Pulmonary Edema

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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CPAP Versus BiPAP in Acute Cardiogenic Pulmonary Edema: Experience With 129 Patients

Conditions
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Acute Cardiogenic Pulmonary Edema

Intervention / Treatment
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* Other: standard therapy (ST)
* Device: CPAP
* Device: BIPAP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: CPE confirmed radiologically and/or clinically Severe acute respiratory failure (partial arterial oxygen (PaO2)/Fraction of inspired oxygen (FIO2) less than 250) Dyspnea of sudden onset with respiratory Systolic blood pressure < 180 mmHg Exclusion Criteria: 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 Severe chronic renal failure Pneumothorax. Contraindication of non invasive ventilation (NIV)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CPAP + ST<br>Continuous positive airway pressure (CPAP) and Standard medical therapy (ST) | Device: CPAP<br>* Non-invasive mechanical ventilation (CPAP)<br>* Other names: noninvasive positive support ventilation (NPSV);|
| Active Comparator: BiPAP + ST<br>Bilevel positive airway pressure (BiPAP) and standard medical therapy (ST) | Device: BIPAP<br>* Non-invasive mechanical ventilation (BIPAP)<br>* Other names: Bilevel Positive Airway Pressure ventilation;|
| Active Comparator: ST<br>Standard Medical therapy (ST) | Other: standard therapy (ST)<br>* standard medical therapy<br>* Other names: Medical treatment of acute cardiogenic pulmonary oedema;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CPE, CPAP, BiPAP, non invasive mechanical ventilation