Non-invasive ventilation
DeviceIn arm description
NCT Number: NCT02977572
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.
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All sexes
Interventional
Not applicable
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. 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. 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
In arm description
In arm description
Time frame: Whitin seven days after onset of cardiopulmonary edema at the Intensive Care Unit
Time frame: Time (hours) from start of ventilation until the removal of both devices because of improve or failure
Period of ventilation (either noninvasive ventilation or continouos positive airway pressure) while the patient suffers from acute respiratory failure secondary to cardiopulmonary edema
Time frame: Pulmonary infection at intensive care unit diagnosed until 72 hours after removal of ventilation
Pulmonary infections (%) during stay at intensive care unit
Time frame: Acute Renal Failure during intensive care unit stay (at discharge from intensive care unit)
Development of acute renal failure measured as increase of level of creatinine
Time frame: Length of stay (days) at Intensive Care Unit at discharge from intensive care unit.
Length of stay of the patient at Intensive Care Unit
Time frame: Length of stay (days) at hospital at discharge from hospital
All the time (days) the patient stays at the hospital
Time frame: Mortality (%) at Intensive Care Unit at discharge from intensive care unit
Mortality (%) at Intensive Care Unit
Time frame: Mortality within 28 days of randomization
Mortility of patients within of the first 28 days after randomization (either at intensive car unit or at hospital)
Time frame: Mortality (%) at Hospital at discharge from hospital
Mortality during hospital stay (including at Intensive care mortality)
Hospital General Universitario de Castellón
Other
Non-Invasive Mechanical Ventilation Versus Continuous Positive Airway Pressure Relating to Cardiogenic Pulmonary Edema in an Intensive Care Unit
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