Cardiogenic Pulmonary Oedema Clinical Trial
Official title:
Non-Invasive Mechanical Ventilation Versus Continuous Positive Airway Pressure Relating to Cardiogenic Pulmonary Edema in an Intensive Care Unit
The aim of the present study was to demonstrate that an Non-Invasive Ventilation (NIV) performs better than a Continuous Positive Airway Pressure (CPAP) in the management of Cardiogenic Pulmonary Edema (CPE) within an Intensive Care Unit (ICU) setting.
Continuous Positive Airway Pressure (CPAP) and Non-Invasive Ventilation (NIV), has played a
decisive role in the treatment of Acute Respiratory Failure (ARF) secondary to Cardiogenic
Pulmonary Edema (CPE). The use of either CPAP or NIV has resulted in greater clinical
improvements than the ones that have been previously obtained by using a standard medical
therapy. Although there is a strong indication for NIV in hypercapnic patients, the
situation whether NIV is superior to CPAP remains unclear, and hence, both have been
recommended.
NIV and CPAP have both been successfully used in patients admitted to an Intensive Care Unit
(ICU) suffering from CPE. However, few trials have been published on the ICU scenario. In
addition, Acute Coronary Syndrome (ACS) has been considered to be an exclusion criterion in
several trials.
At the time of the onset of CPE, either in the Emergency Department (ED) or in the ward, all
participants received a standard medical therapy (oxygen through a Venturi mask, morphine,
intravenous nitroglycerin if their systolic blood pressure >160 mmHg, together with loop
diuretics), all at the discretion of the attending physician. In the absence of a clinical
improvement [dyspnea, respiratory rate >25rpm, transcutaneous arterial oxygen saturation
(SaO2) <90%], the participant was admitted to the ICU and assigned to the NIV group or the
CPAP group, regardless of the treatment that they had received in the ED. The participants
that were admitted to the ICU at the onset of CPE were randomised without a trial of medical
treatment. The assignment of each group was performed by opening a sealed envelope following
a prior randomisation by using a computerised system.
Statistical. Based upon previous results, the investigators considered that the need for an
intubation could be reduced by 15% [19% in the CPAP group (control) vs. 4% in the NIV group
(study)]. The estimated sample size was 55 participants in each group (confidence interval
[1-α] = 90% and power [1-β] = 85%). A comparative analysis was conducted by using the
Student's t-test or the Mann-Whitney test for a comparison of the quantitative variables for
the parametric and non-parametric characteristics, respectively. For the qualitative
variables, the investigators used the Chi-Square statistic or Fisher's exact test. A
statistical significance was reached if P<0.05. A multivariate analysis for the repeated
measures (with Bonferroni's correction) was performed with the aim of studying the influence
of both ventilatory devices on the arterial blood gases (ABG) variables. The cumulative
probability of survival was compared by using a Kaplan-Meier estimation of survival and a
Log-Rank Test to compare both of the groups.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment