Non Invasive Mechanical Ventilation in Acute Cardiogenic Pulmonary Edema

• ClinicalTrials.gov Identifier: NCT00912158
• Recruitment Status: Completed
• First Posted: June 3, 2009
• Results First Posted: June 3, 2009
• Last Update Posted: September 4, 2009
• Sponsor: Assiut University
• Information provided by: Assiut University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Acute Cardiogenic Pulmonary Edema	Other: standard therapy (ST); Device: CPAP; Device: BIPAP	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 129 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: CPAP Versus BiPAP in Acute Cardiogenic Pulmonary Edema: Experience With 129 Patients
• Study Start Date: October 2003
• Actual Primary Completion Date: November 2007
• Actual Study Completion Date: November 2007

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: CPAP + ST; Continuous positive airway pressure (CPAP) and Standard medical therapy (ST)	Device: CPAP; Non-invasive mechanical ventilation (CPAP); Other Names: Continuous postive air way pressure; noninvasive positive support ventilation (NPSV)
Active Comparator: BiPAP + ST; Bilevel positive airway pressure (BiPAP) and standard medical therapy (ST)	Device: BIPAP; Non-invasive mechanical ventilation (BIPAP); Other Name: Bilevel Positive Airway Pressure ventilation
Active Comparator: ST; Standard Medical therapy (ST)	Other: standard therapy (ST); standard medical therapy; Other Name: Medical treatment of acute cardiogenic pulmonary oedema

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

Egypt

Assiut University Hospital

Assiut, Egypt, 71111

Sponsors and Collaborators

Assiut University

Investigators

• Principal Investigator: Gamal M Agmy, MD, FCCP; Chest Department, Faculty of Medicine-Assiut University
• Study Chair: Maha K Ghanem, MD; Chest Department, Faculty of Medicine- Assiut University
• Study Chair: Hoda A Makhlouf, MD; Chest Department, Faculty of Medicine- Assiut University
• Study Chair: Amany O Mohamed, MD; Chest Department, Faculty of Medicine- Assiut University
• Study Chair: Hamdy S Mohamed, MD; Cardiology Department, Faculty of Medicine- Assiut University
• Study Chair: Hatem A Helmy, MD; Cardiology Department, Faculty of Medicine - Assiut University

More Information

Additional Information:

Medscape: Free CME, Medical News, Full-text Journal Articles &amp; More 

U.S. National Library of Medicine &amp; the National Institutes of Health 

The Cochrane library: Evidence for healthcare decision-making 

Publications of Results:

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. Review. Update in: Cochrane Database Syst Rev. 2013;5:CD005351.

Other Publications:

Chadda K, Annane D, Hart N, Gajdos P, Raphaël 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.

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.

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. Review.

• Responsible Party: Prof. Gamal R Agmy, Faculty of Medicine, Assiut University
• ClinicalTrials.gov Identifier: NCT00912158
• Other Study ID Numbers: RICU, Assiut University 1
• First Posted: June 3, 2009
• Results First Posted: June 3, 2009
• Last Update Posted: September 4, 2009
• Last Verified: August 2009

Keywords provided by Assiut University:

CPE; CPAP; BiPAP; non invasive mechanical ventilation

Additional relevant MeSH terms:

Pulmonary Edema; Edema; Lung Diseases; Respiratory Tract Diseases