Phase 4
Completed N=129
Non Invasive Mechanical Ventilation in Acute Cardiogenic Pulmonary Edema
Acute Cardiogenic Pulmonary Edema
Source: ClinicalTrials.gov NCT00912158 ↗
Enrolled (actual)
129
Serious AEs
—
Results posted
Jun 2009
Primary outcomePrimary: Number of Patients Who Were Intubated — 5; 4; 10 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Who Were Intubated |
5; 4; 10 | — |
| 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 |
— | — |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT00912158). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.