Non Invasive Mechanical Ventilation in Acute Cardiogenic Pulmonary Edema

Acute Cardiogenic Pulmonary Edema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00912158
• Other study ID #: RICU, Assiut University 1
• Status: Completed
• Phase: Phase 4
• First received: April 8, 2009
• Last updated: August 17, 2009
• Start date: October 2003
• Est. completion date: November 2007

Study information

• Verified date: August 2009
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Cardiogenic Pulmonary Edema
• Edema
• Pulmonary Edema

Intervention

Other:
• standard therapy (ST)
standard medical therapy

Device:
• CPAP
Non-invasive mechanical ventilation (CPAP)
• BIPAP
Non-invasive mechanical ventilation (BIPAP)

Locations

Country	Name	City	State
Egypt	Assiut University Hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. — View Citation

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. — View 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. — View 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: 10.1002/14651 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients Who Were Intubated		During ICU Stay	Yes
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		Hospital stay	Yes

External Links

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