Non Invasive Mechanical Ventilation in Acute Cardiogenic Pulmonary Edema

• Sponsor: Assiut University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00912158
• Collaborator: (none)
• Enrollment: 129
• Location: 1
• Arms: 3
• Duration (Months): 49
• Patients Per Site Per Month: 2.6

Study Details

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
• 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: Oct 1, 2003
• Actual Primary Completion Date: Nov 1, 2007
• Actual Study Completion Date: Nov 1, 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 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

Outcome Measures

Primary Outcome Measures

1. Number of Patients Who Were Intubated [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 [Hospital stay]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

1. Severe chronic renal failure

2. Pneumothorax.

3. Contraindication of non invasive ventilation (NIV)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• 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

Publications

• 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.
• 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.

• ClinicalTrials.gov Identifier: NCT00912158
• Other Study ID Numbers: RICU, Assiut University 1
• First Posted: Jun 3, 2009
• Last Update Posted: Sep 4, 2009
• Last Verified: Aug 1, 2009

• Keywords provided by , ,: CPE; CPAP; BiPAP; non invasive mechanical ventilation
• Additional relevant MeSH terms: Pulmonary Edema; Edema

Study Results

Participant Flow

Recruitment Details	Location: Respiratory and Coronary Intensive Care Units of Assiut University Hospital. Patients with acute cardiogenic pulmonary oedema (CPE)
Pre-assignment Detail	All enrolled participants were assigned to one of the three studied groups.

Arm/Group Title	CPAP+ST	BiPAP + ST	Standard Treatment
Arm/Group Description	Continuous positive airway pressure plus standard medical therapy	Bilevel positive airway pressure + standard medical therapy	Standard medical therapy alone
Period Title: Overall Study
STARTED	44	44	41
COMPLETED	44	44	41
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	CPAP+ST	BiPAP + ST	Standard Treatment	Total
Arm/Group Description	Continuous positive airway pressure plus standard medical therapy	Bilevel positive airway pressure + standard medical therapy	Standard medical therapy alone	Total of all reporting groups
Overall Participants	44	44	41	129
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	14 31.8%	12 27.3%	10 24.4%	36 27.9%
>=65 years	30 68.2%	32 72.7%	31 75.6%	93 72.1%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66 (6.9)	68 (3.8)	69 (5.8)	67 (4.8)
Sex: Female, Male (Count of Participants)
Female	14 31.8%	12 27.3%	10 24.4%	36 27.9%
Male	30 68.2%	32 72.7%	31 75.6%	93 72.1%
Region of Enrollment (participants) [Number]
Egypt	44 100%	44 100%	41 100%	129 100%

Outcome Measures

1. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CPAP+ST	BiPAP + ST	Standard Treatment
Arm/Group Description	Continuous positive airway pressure plus standard medical therapy	Bilevel positive airway pressure + standard medical therapy	Standard medical therapy alone
Measure Participants	44	44	41
Number [participants]	5 11.4%	4 9.1%	10 24.4%

Adverse Events

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.