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

Efficacy of Noninvasive Bilevel versus Continuous Positive Airway Pressure on blood gases in Acute Cardiogenic Pulmonary Edema: A Single Blinded Randomized Trial

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614001208695

Enrollment

Registered

2014-11-17

Start date

2007-05-13

Completion date

2008-11-20

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

50 Years to 65 Years

Healthy volunteers

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].

Outcome results