Non-invasive Ventilation Versus Continuous Positive Airway Pressure in Cardiogenic Pulmonary Edema

Not Applicable

Completed

Conditions: Cardiogenic Pulmonary Oedema

Registration Number: NCT02977572

Lead Sponsor: Hospital General Universitario de Castellón

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 114

Inclusion Criteria

Participants suffering from CPE, defined as having the presence of dyspnea, respiratory rate >25 breaths/minute, the use of accessory respiratory muscles, cyanosis, cold sweats, bilateral crackles and/or wheezing on pulmonary auscultation, hypoxaemia, hypertension, and a predominance of bilateral pulmonary infiltrates upon a chest radiography (if available).
The potential causes of CPE have been understood to be Acute Coronary Syndrome (ACS) with or without a persistent ST-segment elevation, hypertensive emergency, valvulopathy, acute arrhythmia, endocarditis, or decompensation due to a chronic heart failure.

Exclusion Criteria

The exclusion criteria were: a refused consent, the patient's inability to cooperate, severe encephalopathy (Glasgow Coma Score <10)
Anatomical difficulty when adjusting the face mask, non-cardiogenic Acute Respiratory Failure (pneumonia, blunt chest trauma, or chronic obstructive pulmonary disease)
Respiratory or cardiac arrest on admission, together with the need for an immediate intubation.
Specific cardiac contraindications were also considered, including: cardiogenic shock on admission established by systolic blood pressure (SBP) <90 mmHg, or a dependence on vasoactive drugs (norepinephrine >0.5 µg/kg/min).

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Need for an Endotracheal Intubation Within Seven Days After Onset of Cardiopulmonary Edema at the Intensive Care Unit	Whitin seven days after onset of cardiopulmonary edema at the Intensive Care Unit

Secondary Outcome Measures

Name	Time	Method
Duration of the Ventilation	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
Ventilator Acquired Pneumonia	Pulmonary infection at intensive care unit diagnosed until 72 hours after removal of ventilation	Pulmonary infections (%) during stay at intensive care unit
Acute Renal Failure	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
Length of Stay at Intensive Care Unit	Length of stay (days) at Intensive Care Unit at discharge from intensive care unit.	Length of stay of the patient at Intensive Care Unit
Length of Hospital Stay	Length of stay (days) at hospital at discharge from hospital	All the time (days) the patient stays at the hospital
Intensive Care Unit Mortality	Mortality (%) at Intensive Care Unit at discharge from intensive care unit	Mortality (%) at Intensive Care Unit
28th Day Mortality	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)
Hospital Mortality	Mortality (%) at Hospital at discharge from hospital	Mortality during hospital stay (including at Intensive care mortality)