Non Invasive Mechanical Ventilation in Acute Cardiogenic Pulmonary Edema

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Cardiogenic Pulmonary Edema
• Intervention / Treatment: Device: CPAP; Device: BIPAP; Other: standard therapy (ST)

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 Type: Interventional
• Enrollment (Actual): 129
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71111
    • Assiut University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: Bilevel Positive Airway Pressure ventilation
ACTIVE_COMPARATOR: ST; Standard Medical therapy (ST)	Other: standard therapy (ST); standard medical therapy; Other Names: Medical treatment of acute cardiogenic pulmonary oedema

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients Who Were Intubated	Number of patients who were subjected to endotracheal intubation and invasive mechanical ventilation	During ICU Stay

Secondary Outcome Measures

Outcome Measure	Time Frame
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	Hospital stay

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• 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.
• 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. doi: 10.1136/pgmj.2004.031229.
• 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.

Helpful Links

• Medscape: Free CME, Medical News, Full-text Journal Articles & More
• U.S. National Library of Medicine & the National Institutes of Health
• The Cochrane library: Evidence for healthcare decision-making

Study record dates

Study Major Dates

• Study Start: October 1, 2003
• Primary Completion (ACTUAL): November 1, 2007
• Study Completion (ACTUAL): November 1, 2007

Study Registration Dates

• First Submitted: April 8, 2009
• First Submitted That Met QC Criteria: April 9, 2009
• First Posted (ESTIMATE): June 3, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): September 4, 2009
• Last Update Submitted That Met QC Criteria: August 17, 2009
• Last Verified: August 1, 2009

More Information

Terms related to this study

• Keywords: CPAP; CPE; BiPAP; non invasive mechanical ventilation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Edema; Pulmonary Edema
• Other Study ID Numbers: RICU, Assiut University 1