Non Invasive Mechanical Ventilation in Acute Cardiogenic Pulmonary Edema

Assiut University

Status and phase: Completed; Phase 4

Conditions: Acute Cardiogenic Pulmonary Edema

Treatments: Device: CPAP; Other: standard therapy (ST); Device: BIPAP

Study type: Interventional

Funder types: Other

Identifiers

NCT00912158

RICU, Assiut University 1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 129 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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129 participants in 3 patient groups

CPAP + ST

Active Comparator group

Description:

Continuous positive airway pressure (CPAP) and Standard medical therapy (ST)

Treatment:

Device: CPAP

BiPAP + ST

Active Comparator group

Description:

Bilevel positive airway pressure (BiPAP) and standard medical therapy (ST)

Treatment:

Device: BIPAP

ST

Active Comparator group

Description:

Standard Medical therapy (ST)

Treatment:

Other: standard therapy (ST)