Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    18614781 [PUBMED-IDS]
Previous Study | Return to List | Next Study

Non Invasive Mechanical Ventilation in Acute Cardiogenic Pulmonary Edema

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00912158
Recruitment Status : Completed
First Posted : June 3, 2009
Results First Posted : June 3, 2009
Last Update Posted : September 4, 2009
Sponsor:
Information provided by:
Assiut University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Acute Cardiogenic Pulmonary Edema
Interventions Other: standard therapy (ST)
Device: CPAP
Device: BIPAP
Enrollment 129
Recruitment Details Location: Respiratory and Coronary Intensive Care Units of Assiut University Hospital. Patients with acute cardiogenic pulmonary oedema (CPE)
Pre-assignment Details All enrolled participants were assigned to one of the three studied groups.
Arm/Group Title CPAP+ST BiPAP + ST Standard Treatment
Hide 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
Arm/Group Title CPAP+ST BiPAP + ST Standard Treatment Total
Hide 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 Number of Baseline Participants 44 44 41 129
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 44 participants 41 participants 129 participants
<=18 years
0
   0.0%
0
   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 Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 44 participants 44 participants 41 participants 129 participants
66  (6.9) 68  (3.8) 69  (5.8) 67  (4.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 44 participants 41 participants 129 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  
Measure Type: Number
Unit of measure:  Participants
Egypt Number Analyzed 44 participants 44 participants 41 participants 129 participants
44 44 41 129
1.Primary Outcome
Title Number of Patients Who Were Intubated
Hide Description Number of patients who were subjected to endotracheal intubation and invasive mechanical ventilation
Time Frame During ICU Stay
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CPAP+ST BiPAP + ST Standard Treatment
Hide Arm/Group Description:
Continuous positive airway pressure plus standard medical therapy
Bilevel positive airway pressure + standard medical therapy
Standard medical therapy alone
Overall Number of Participants Analyzed 44 44 41
Measure Type: Number
Unit of Measure: participants
5 4 10
2.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
Hide Description [Not Specified]
Time Frame Hospital stay
Outcome Measure Data Not Reported
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Maha K Ghanem, MD, FCCP
Organization: Chest Department, Faculty of Medicine, Assiut University- EGYPT
Phone: + 2 0127694434
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
First Submitted: April 8, 2009
First Posted: June 3, 2009
Results First Submitted: April 8, 2009
Results First Posted: June 3, 2009
Last Update Posted: September 4, 2009