Comparison of Bilevel and Continuous Positive Airway Pressure Noninvasive Ventilation in Acute Cardiogenic Pulmonary Edema

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12614001208695
• Date of registration: 17/11/2014
• Prospective Registration: No
• Primary sponsor: Rehab Farrag Gwada
• 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
• Date of first enrolment: 13/05/2007
• Target sample size: 69
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12614001208695.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Phase 3 / Phase 4

Countries of recruitment

Egypt

Contacts

• Name: Dr Rehab Farrag Gwada

• Name: Dr Rehab Farrag Gwada

Key inclusion & exclusion criteria

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].
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].

Age minimum: 50 Years
Age maximum: 65 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Cardiovascular - Other cardiovascular diseases

Respiratory - Other respiratory disorders / diseases

Acute cardiogenic pulmonary edema ;
Acute cardiogenic pulmonary edema

Intervention(s)

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.

Primary Outcome(s)

The primary outcome measures were physiological parameters concerning blood gases (PaCO2,PaO2, SaO2, pH, and HCO3).[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. ]

vital signs were continuously monitored using ECG monitor (Hewlett Packard M1092-Italy) to detect their changes .[ 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(s)

Secondary outcomes were rate of endotracheal intubation[secondary outcome were reported at the time of discharge.]

the rate of death.[at time of discharge]

Secondary ID(s)

Nil

Secondary Sponsor(s)

Bassem S, Ibrahim.

Basant Hamdy El-Refay

Ethics review

Status: Approved
Approval date:
Contact:

postgraduate ethics committee , faculty physical therapy, Cairo university.