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Completed

NCT Number: NCT00912158

Non Invasive Mechanical Ventilation in Acute Cardiogenic Pulmonary Edema

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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Key information

Conditions

Acute Cardiogenic Pulmonary Edema

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Assiut University Hospital

Asyut, 71111, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

standard therapy (ST)

Other

standard medical therapy

Other names: Medical treatment of acute cardiogenic pulmonary oedema

CPAP

Device

Non-invasive mechanical ventilation (CPAP)

Other names: Continuous postive air way pressure, noninvasive positive support ventilation (NPSV)

BiPAP

Device

Non-invasive mechanical ventilation (BIPAP)

Other names: Bilevel Positive Airway Pressure ventilation

Primary outcomes

  1. Number of Patients Who Were Intubated

    Time frame: During ICU Stay

    Number of patients who were subjected to endotracheal intubation and invasive mechanical ventilation

Secondary outcomes

  1. 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

    Time frame: Hospital stay

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2007
Study completion
2007
First posted
Jun 3, 2009
Registry last updated
Sep 4, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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