Clinical trial NCT02977572: Non-invasive Ventilation Versus Continuous Positive Airway Pressure in Cardiogenic Pulmonary Edema
Official title: Non-Invasive Mechanical Ventilation Versus Continuous Positive Airway Pressure Relating to Cardiogenic Pulmonary Edema in an Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiogenic Pulmonary Oedema
Keywords: Non-invasive ventilation,
continuous positive airway pressure
cardiogenic pulmonary oedema,
acute respiratory failure
Lead sponsor: Hospital General Universitario de Castellón
Sponsor class: OTHER
First posted: 2016-11-30
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Need for an Endotracheal Intubation Within Seven Days After Onset of Cardiopulmonary Edema at the Intensive Care Unit
timeFrame: Whitin seven days after onset of cardiopulmonary edema at the Intensive Care Unit
Secondary outcomes:
measure: Duration of the Ventilation
timeFrame: Time (hours) from start of ventilation until the removal of both devices because of improve or failure
measure: Ventilator Acquired Pneumonia
timeFrame: Pulmonary infection at intensive care unit diagnosed until 72 hours after removal of ventilation
measure: Acute Renal Failure
timeFrame: Acute Renal Failure during intensive care unit stay (at discharge from intensive care unit)
measure: Length of Stay at Intensive Care Unit
timeFrame: Length of stay (days) at Intensive Care Unit at discharge from intensive care unit.
measure: Length of Hospital Stay
timeFrame: Length of stay (days) at hospital at discharge from hospital
measure: Intensive Care Unit Mortality
timeFrame: Mortality (%) at Intensive Care Unit at discharge from intensive care unit
measure: 28th Day Mortality
timeFrame: Mortality within 28 days of randomization
measure: Hospital Mortality
timeFrame: Mortality (%) at Hospital at discharge from hospital
Other outcomes:
Locations:
Study officials:
affiliation: INTENSIVE CARE UNIT. HOSPITAL GENERAL CASTELLO
name: ALBERTO BELENGUER-MUNCHARAZ, MD
role: PRINCIPAL_INVESTIGATOR
References: