Non Invasive Mechanical Ventilation in Acute Cardiogenic Pulmonary Edema

This study has been completed.

Sponsor:

Information provided by:

Assiut University

ClinicalTrials.gov Identifier:

NCT00912158

First received: April 8, 2009

Last updated: August 17, 2009

Last verified: August 2009

History of Changes

Results First Received: April 8, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Acute Cardiogenic Pulmonary Edema
Interventions:	Other: standard therapy (ST) Device: CPAP Device: BIPAP

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Location: Respiratory and Coronary Intensive Care Units of Assiut University Hospital. Patients with acute cardiogenic pulmonary oedema (CPE)

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All enrolled participants were assigned to one of the three studied groups.

Reporting Groups

	Description
CPAP+ST	Continuous positive airway pressure plus standard medical therapy
BiPAP + ST	Bilevel positive airway pressure + standard medical therapy
Standard Treatment	Standard medical therapy alone

Participant Flow: Overall Study

	CPAP+ST	BiPAP + ST	Standard Treatment
STARTED	44	44	41
COMPLETED	44	44	41
NOT COMPLETED	0	0	0

Baseline Characteristics

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Reporting Groups

	Description
CPAP+ST	Continuous positive airway pressure plus standard medical therapy
BiPAP + ST	Bilevel positive airway pressure + standard medical therapy
Standard Treatment	Standard medical therapy alone
Total	Total of all reporting groups

Baseline Measures

	CPAP+ST	BiPAP + ST	Standard Treatment	Total
Number of Participants [units: participants]	44	44	41	129
Age [units: participants]
<=18 years	0	0	0	0
Between 18 and 65 years	14	12	10	36
>=65 years	30	32	31	93
Age [units: years] Mean ± Standard Deviation	66 ± 6.9	68 ± 3.8	69 ± 5.8	67 ± 4.8
Gender [units: participants]
Female	14	12	10	36
Male	30	32	31	93
Region of Enrollment [units: participants]
Egypt	44	44	41	129

Outcome Measures

1. Primary:

Number of Patients Who Were Intubated [ Time Frame: During ICU Stay ]

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2. 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 [ Time Frame: Hospital stay ]

Results not yet posted. Anticipated Posting Date: 01/2010 Safety Issue: Yes

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

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

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Dr. Maha K Ghanem, MD, FCCP
Organization: Chest Department, Faculty of Medicine, Assiut University- EGYPT
phone: + 2 0127694434
e-mail: mahaghanem@hotmail.com

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. Review.

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.

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 History of Changes
Other Study ID Numbers:	RICU, Assiut University 1
Study First Received:	April 8, 2009
Results First Received:	April 8, 2009
Last Updated:	August 17, 2009
Health Authority:	Egypt: Institutional Review Board

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