Non Invasive Mechanical Ventilation in Acute Cardiogenic Pulmonary Edema

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2007-11-30

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.

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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.

Conditions

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Acute Cardiogenic Pulmonary Edema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CPAP + ST

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

Group Type ACTIVE_COMPARATOR

CPAP

Intervention Type DEVICE

Non-invasive mechanical ventilation (CPAP)

BiPAP + ST

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

Group Type ACTIVE_COMPARATOR

BIPAP

Intervention Type DEVICE

Non-invasive mechanical ventilation (BIPAP)

ST

Standard Medical therapy (ST)

Group Type ACTIVE_COMPARATOR

standard therapy (ST)

Intervention Type OTHER

standard medical therapy

Interventions

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standard therapy (ST)

standard medical therapy

Intervention Type OTHER

CPAP

Non-invasive mechanical ventilation (CPAP)

Intervention Type DEVICE

BIPAP

Non-invasive mechanical ventilation (BIPAP)

Intervention Type DEVICE

Other Intervention Names

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Medical treatment of acute cardiogenic pulmonary oedema Continuous postive air way pressure noninvasive positive support ventilation (NPSV) Bilevel Positive Airway Pressure ventilation

Eligibility 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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No