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Phase 4 N=129 Randomized Treatment

Non Invasive Mechanical Ventilation in Acute Cardiogenic Pulmonary Edema

Acute Cardiogenic Pulmonary Edema

Bottom Line

View on ClinicalTrials.gov: NCT00912158 ↗
Enrolled (actual)
129
Serious AEs
—
Results posted
Jun 2009
Primary outcome: Primary: Number of Patients Who Were Intubated — 5; 4; 10 participants

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
standard therapy (ST) (Other); CPAP (Device); BIPAP (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Assiut University
Primary completion
Nov 2007

Outcome Measures

OutcomeResultp-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		 — —

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.

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)
View full record on ClinicalTrials.gov →

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.

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