Clinical trial NCT00912158: Non Invasive Mechanical Ventilation in Acute Cardiogenic Pulmonary Edema
Official title: CPAP Versus BiPAP in Acute Cardiogenic Pulmonary Edema: Experience With 129 Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Cardiogenic Pulmonary Edema
Keywords: CPE
CPAP
BiPAP
non invasive mechanical ventilation
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2009-06-03
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of Patients Who Were Intubated
timeFrame: During ICU Stay
Secondary outcomes:
measure: 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
timeFrame: Hospital stay
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hospital
Study officials:
affiliation: Chest Department, Faculty of Medicine-Assiut University
name: Gamal M Agmy, MD, FCCP
role: PRINCIPAL_INVESTIGATOR
affiliation: Chest Department, Faculty of Medicine- Assiut University
name: Maha K Ghanem, MD
role: STUDY_CHAIR
affiliation: Chest Department, Faculty of Medicine- Assiut University
name: Hoda A Makhlouf, MD
role: STUDY_CHAIR
affiliation: Chest Department, Faculty of Medicine- Assiut University
name: Amany O Mohamed, MD
role: STUDY_CHAIR
affiliation: Cardiology Department, Faculty of Medicine- Assiut University
name: Hamdy S Mohamed, MD
role: STUDY_CHAIR
affiliation: Cardiology Department, Faculty of Medicine - Assiut University
name: Hatem A Helmy, MD
role: STUDY_CHAIR
References:
citation: Chadda K, Annane D, Hart N, Gajdos P, Raphael JC, Lofaso F. Cardiac and respiratory effects of continuous positive airway pressure and noninvasive ventilation in acute cardiac pulmonary edema. Crit Care Med. 2002 Nov;30(11):2457-61. doi: 10.1097/00003246-200211000-00009.
citation: Gray A, Goodacre S, Newby DE, Masson M, Sampson F, Nicholl J; 3CPO Trialists. Noninvasive ventilation in acute cardiogenic pulmonary edema. N Engl J Med. 2008 Jul 10;359(2):142-51. doi: 10.1056/NEJMoa0707992.
citation: Agarwal R, Aggarwal AN, Gupta D, Jindal SK. Non-invasive ventilation in acute cardiogenic pulmonary oedema. Postgrad Med J. 2005 Oct;81(960):637-43. doi: 10.1136/pgmj.2004.031229.
citation: Vital FM, Saconato H, Ladeira MT, Sen A, Hawkes CA, Soares B, Burns KE, Atallah AN. Non-invasive positive pressure ventilation (CPAP or bilevel NPPV) for cardiogenic pulmonary edema. Cochrane Database Syst Rev. 2008 Jul 16;(3):CD005351. doi: 10.1002/14651858.CD005351.pub2.