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Trial registered on ANZCTR


Registration number
ACTRN12614001208695
Ethics application status
Approved
Date submitted
6/10/2014
Date registered
17/11/2014
Date last updated
17/11/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of Bilevel and Continuous Positive Airway Pressure Noninvasive Ventilation in Acute Cardiogenic Pulmonary Edema
Scientific title
Efficacy of Noninvasive Bilevel versus Continuous Positive Airway Pressure on blood gases in Acute Cardiogenic Pulmonary Edema: A Single Blinded Randomized Trial
Secondary ID [1] 285445 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute cardiogenic pulmonary edema 293212 0
Condition category
Condition code
Cardiovascular 293481 293481 0 0
Other cardiovascular diseases
Respiratory 293637 293637 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
both treatment groups(1and 2) received the standard medical treatment in addition to NIV .The NIV were delivered through a full-face mask by a Respironics Synchrony ventilator (Model RTX Inodes, 10 Downage RespiCare, Drager, London). In the CPAP group(group1) a continuous pressure of 10 cmH2O was generated. Patients in Bi-PAP group(group 2) received IPAP (15 cmH2O) and EPAP (5 cmH2O)
. All patients received their assigned treatment for 1 hour. After NIV mask remove the patients continued to receive standardO2 face mask.

Criteria for termination of noninvasive ventilation therapy include inability to tolerate the tightness of the mask or pressure, abundant secretion or met the criteria for intubation according to Brochard et al. 1995. In those who were unable to tolerate the NIV, it was stopped and standard face mask O2 applied.After study period(90 minutes), the patients were transferred to medical ward or admitted to an intensive care unit(ICU) if they require intubation or did not improve.
Intervention code [1] 290377 0
Treatment: Devices
Comparator / control treatment
Patients were helped to assume a semi-recumbent position. patients of control group ( group 3 ) received the standard medical treatment only , according to the emergency department protocol, at the National Heart Institute. These included:1)supplementary oxygen therapy was supplied at a rate of up to 15 liters per minute via a reservoir mask to maintain oxygen saturation greater than or equal to90%; 2), nitroglycerine 0.4 mg sublingual if systolic BPgreater than100 mmHg-excluding patients receiving potential drug interaction preparations, doses can be repeated every 5 minutes;3) frusemide IV starts with 40 mg and in incremental doses if required; 4)morphine sulfate 2 mg IV, may be repeated once. If BP less than 100mmHg dopamine is given starting at 2.5 mcg/Kg/min intravenous and increase dose every 10 minutes if BP remains low .
Control group
Active

Outcomes
Primary outcome [1] 293303 0
The primary outcome measures were physiological parameters concerning blood gases (PaCO2,PaO2, SaO2, pH, and HCO3).
Timepoint [1] 293303 0
The primary outcomes collected before entry of the study (T0), immediately after60minutes of noninvasive ventilation application (T60), and after 30 minutes (T90) of noninvasive ventilation discontinuation.
Primary outcome [2] 293457 0
vital signs were continuously monitored using ECG monitor (Hewlett Packard M1092-Italy) to detect their changes .
Timepoint [2] 293457 0
collected before entry of the study (T0), immediately after 60minutes of noninvasive ventilation application (T60), and after 30 minutes (T90) of noninvasive ventilation discontinuation
Secondary outcome [1] 310771 0
Secondary outcomes were rate of endotracheal intubation
Timepoint [1] 310771 0
secondary outcome were reported at the time of discharge.
Secondary outcome [2] 311077 0
the rate of death.
Timepoint [2] 311077 0
at time of discharge

Eligibility
Key inclusion criteria
Inclusion criteria were: severe dyspnea, bilateral rales on auscultation, and typical findings of congestion on chest radiography without evidence of pulmonary aspiration or pneumonia. In addition, respiratory rate of geater than or equal to 30 breaths per minute, hypoxemia (PaO2 less than80mmHg) with a fraction of inspired oxygen (Fio2) of 60% via a Venturi mask, and PaCO2 less than or equal to 45mmHg[ Nouira et.al 2011 and Ferrari et.al 2009].
Minimum age
50 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The patients were excluded from this study if they required a lifesaving or emergency intervention, such as primary percutaneous coronary intervention, or if they had chronic obstructive pulmonary diseases, hemodynamic instability (systolic BP less than or equal to 90mmHg), or life threatening arrthymia, acute myocardial infarction and/ or unstable angina, recent facial trauma, and esophageal/gastric surgery, gastrointestinal bleeding, or pregnant [Ferrari et.al 2007and Bellone et.al 2005].

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomization was performed using an opaque envelope, which was then further concealed within another. Once enrolled within the study it was impossible to mask treatment allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation). .
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Statistical analyses were performed using the Statistical Package for the Social Sciences (SPSS) version 21.0. Continuous variables were presented as mean and standard deviation while categorical variables were described by frequency and percentage. A one way repeated measure analysis of variance (ANOVA), with the Scheffe test for repeated comparison was used to identify specific differences within and between groups at each time point.Variables without normal distribution and homogeneous variance were analyzed with the Kruskal-Wallis test. All statistical analysis was two-tailed with statistical significant differences was assumed at p =0.05.
The sample size was estimated to be 60 patients in all groups and would be increased to 69 for possible dropout. This sample size was estimated to detect 5terro (0.7PKa) difference in PaCO2 between groups, with the probability level was set at 0.05 and power of 80% [Mehta et al. 1997

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 6392 0
Egypt
State/province [1] 6392 0
Giza/Imbaba

Funding & Sponsors
Funding source category [1] 290052 0
Self funded/Unfunded
Name [1] 290052 0
Address [1] 290052 0
Country [1] 290052 0
Primary sponsor type
Individual
Name
Rehab Farrag Gwada
Address
Department of physical therapy, National Heart Institute,9 Omar Tosoon street , Kitkat, Giza, Egypt
Postal Code: 12312
Country
Egypt
Secondary sponsor category [1] 288740 0
Individual
Name [1] 288740 0
Basant Hamdy El-Refay
Address [1] 288740 0
Cairo University, Faculty of Physical Therapy, Physical Therapy Department for Cardiopulmonary Disorders, 7 Ahmad Alzayat St., Bain El-sarayat, Giza, Egypt.
Postal Code: 12612
Country [1] 288740 0
Egypt
Secondary sponsor category [2] 288741 0
Individual
Name [2] 288741 0
Bassem S, Ibrahim.
Address [2] 288741 0
National Heart Institute,9 Omar Tosoon street , Kitkat, Giza, Egypt.
Postal Code :12312
Country [2] 288741 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291759 0
postgraduate ethics committee , faculty physical therapy, Cairo university.
Ethics committee address [1] 291759 0
Cairo University, Faculty of Physical Therapy, 7 Ahmad Alzayat St., Bain El-sarayat, Giza, Egypt.
Postal Code: 12612
Ethics committee country [1] 291759 0
Egypt
Date submitted for ethics approval [1] 291759 0
Approval date [1] 291759 0
04/02/2007
Ethics approval number [1] 291759 0

Summary
Brief summary
Acute cardiogenic pulmonary edema (ACPE) is one of the most common emergency medical conditions leading to hospitalization, with the associated higher rate of mortality, especially when it is coupled with acute myocardial infarction (AMI (.
As many patients with ACPE respond rapidly to standardized medical treatment includes oxygen, diuretics, and vasodilators that could improve the symptoms. However, a significant number of patients required endotracheal intubation and ventilation, with its associated potential for complications.
Over the past two decades, application of noninvasive ventilation(NIV) either with continuous positive airway pressure (CPAP) or Bi-level positive airway pressure (Bi-PAP) has been suggested in association with the standardized medical treatment as an effective approach to treat ACPE. These due to augmentation of cardiac output and oxygen delivery, improved function residual capacity and respiratory mechanism, reduced effort in breathing, and decreased left ventricular preload and after load.

Most studies evaluating CPAP and Bi-PAP have variable conclusions. As most of these studies were case series, and small, randomized trials, with considerable variation in study populations, the type of ventilation intervention, concomitant therapies, and outcome measurements. Moreover, the results from these studies are inconsistent.
In addition, there are no or few clinical studies that investigated the role of NIV on ACPE in emergency departments in Egypt.
Therefore, the current study was conducted to compare the efficacy of CPAP, Bi-PAP, and standard oxygen therapy on blood gases and vital signs in patients with ACPE, and to investigate whether either CPAP or Bi-PAP would cause improvement in endotracheal intubation and mortality rates.
Trial website
Trial related presentations / publications
not applicable
Public notes

Contacts
Principal investigator
Name 51902 0
Dr Rehab Farrag Gwada
Address 51902 0
Department of physical therapy, National Heart Institute,9 Omar Tosoon street , Kitkat, Giza, Egypt
Postal Code: 12312
Country 51902 0
Egypt
Phone 51902 0
+20 222524015
Fax 51902 0
Email 51902 0
rehabfarrag40@yahoo.com
Contact person for public queries
Name 51903 0
Dr Rehab Farrag Gwada
Address 51903 0
Department of physical therapy, National Heart Institute,9 Omar Tosoon street , Kitkat, Giza, Egypt
Postal Code: 12312
Country 51903 0
Egypt
Phone 51903 0
+20 222524015
Fax 51903 0
Email 51903 0
rehabfarrag40@yahoo.com
Contact person for scientific queries
Name 51904 0
Dr Rehab Farrag Gwada
Address 51904 0
Department of physical therapy, National Heart Institute,9 Omar Tosoon street , Kitkat, Giza, Egypt
Postal Code: 12312
Country 51904 0
Egypt
Phone 51904 0
+20 222524015
Fax 51904 0
Email 51904 0
rehabfarrag40@yahoo.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary