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Non Invasive Mechanical Ventilation in Acute Cardiogenic Pulmonary Edema

Primary Purpose

Acute Cardiogenic Pulmonary Edema

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
standard therapy (ST)
CPAP
BIPAP
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Cardiogenic Pulmonary Edema focused on measuring CPE, CPAP, BiPAP, non invasive mechanical ventilation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Assiut University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

CPAP + ST

BiPAP + ST

ST

Arm Description

Continuous positive airway pressure (CPAP) and Standard medical therapy (ST)

Bilevel positive airway pressure (BiPAP) and standard medical therapy (ST)

Standard Medical therapy (ST)

Outcomes

Primary Outcome Measures

Number of Patients Who Were Intubated
Number of patients who were subjected to endotracheal intubation and invasive mechanical ventilation

Secondary Outcome Measures

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

Full Information

First Posted
April 8, 2009
Last Updated
August 17, 2009
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT00912158
Brief Title
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

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Assiut University

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Cardiogenic Pulmonary Edema
Keywords
CPE, CPAP, BiPAP, non invasive mechanical ventilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
129 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CPAP + ST
Arm Type
Active Comparator
Arm Description
Continuous positive airway pressure (CPAP) and Standard medical therapy (ST)
Arm Title
BiPAP + ST
Arm Type
Active Comparator
Arm Description
Bilevel positive airway pressure (BiPAP) and standard medical therapy (ST)
Arm Title
ST
Arm Type
Active Comparator
Arm Description
Standard Medical therapy (ST)
Intervention Type
Other
Intervention Name(s)
standard therapy (ST)
Other Intervention Name(s)
Medical treatment of acute cardiogenic pulmonary oedema
Intervention Description
standard medical therapy
Intervention Type
Device
Intervention Name(s)
CPAP
Other Intervention Name(s)
Continuous postive air way pressure, noninvasive positive support ventilation (NPSV)
Intervention Description
Non-invasive mechanical ventilation (CPAP)
Intervention Type
Device
Intervention Name(s)
BIPAP
Other Intervention Name(s)
Bilevel Positive Airway Pressure ventilation
Intervention Description
Non-invasive mechanical ventilation (BIPAP)
Primary Outcome Measure Information:
Title
Number of Patients Who Were Intubated
Description
Number of patients who were subjected to endotracheal intubation and invasive mechanical ventilation
Time Frame
During ICU Stay
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gamal M Agmy, MD, FCCP
Organizational Affiliation
Chest Department, Faculty of Medicine-Assiut University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maha K Ghanem, MD
Organizational Affiliation
Chest Department, Faculty of Medicine- Assiut University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hoda A Makhlouf, MD
Organizational Affiliation
Chest Department, Faculty of Medicine- Assiut University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Amany O Mohamed, MD
Organizational Affiliation
Chest Department, Faculty of Medicine- Assiut University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hamdy S Mohamed, MD
Organizational Affiliation
Cardiology Department, Faculty of Medicine- Assiut University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hatem A Helmy, MD
Organizational Affiliation
Cardiology Department, Faculty of Medicine - Assiut University
Official's Role
Study Chair
Facility Information:
Facility Name
Assiut University Hospital
City
Assiut
ZIP/Postal Code
71111
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
12441754
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.
Results Reference
background
PubMed Identifier
18614781
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.
Results Reference
background
PubMed Identifier
16210459
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.
Results Reference
background
PubMed Identifier
18646124
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.
Results Reference
result
Links:
URL
http://www.medscape.com
Description
Medscape: Free CME, Medical News, Full-text Journal Articles & More
URL
http://www.pubMed.gov
Description
U.S. National Library of Medicine & the National Institutes of Health
URL
http://www.cochrane.org
Description
The Cochrane library: Evidence for healthcare decision-making

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Non Invasive Mechanical Ventilation in Acute Cardiogenic Pulmonary Edema

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