Cardiogenic Pulmonary Oedema
Conditions
Keywords
Non-invasive ventilation,, continuous positive airway pressure, cardiogenic pulmonary oedema,, acute respiratory failure
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.
Interventions
DEVICENon-Invasive Ventilation
In arm description
DEVICEContinuous Positive AirwayPressure CPAP
In arm description
Sponsors
Hospital General Universitario de Castellón
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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) |
| Length of Hospital Stay | Length of stay (days) at hospital at discharge from hospital | All the time (days) the patient stays at the hospital |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Continuous Positive Airway Pressure (CPAP) Group The CPAP was applied by using a flow generator that was capable of delivering a flow of 140 Liter /minute, with adjustable fractional inspired oxygen (FiO2) that ranged from 0.3 to 1.0. This was connected to the Positive End-Expiratory Pressure (PEEP) valve that was placed in the face mask. In the second instance, the CPAP system that was used was a Boussignac CPAP System Flow Jet. The Boussignac valve takes gas from a single source and splits it in order to create four high flow jets. These jets converge in the chamber creating a turbulence which creates a virtual valve. A minimal initial level of 5cmH20 of PEEP was recommended for the first hour of the CPAP, with subsequent increments (up to 15cmH20) until a clinical improvement was obtained. CPAP was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4.
Continuous Positive Airway Pressure: In arm description | 54 |
| Non-Invasive Ventilation (NIV Group) For the NIV group, a BiPAP Vision was used, by setting the Inspiratory Positive Airway Pressure (IPAP) at a level that was required to achieve a tidal volume of approximately 8-10 ml/kg. Also an Expiratory Positive Airway Pressure (EPAP) was set at a minimum of 5 cmH20 during the first hour, gradually increasing until there was a clinical improvement. Fraction inspiratory of oxygen (FiO2) was applied to maintain a transcutaneous arterial oxygen saturation (SaO2) of 92%-94%. NIV was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4.
Non-Invasive Ventilation: In arm description | 56 |
| Total | 110 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Exclusion criterion | 2 | 2 |
Baseline characteristics
| Characteristic | Continuous Positive Airway Pressure (CPAP) Group | Non-Invasive Ventilation (NIV Group) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 40 Participants | 38 Participants | 78 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 18 Participants | 32 Participants |
| Sex: Female, Male Female | 19 Participants | 14 Participants | 33 Participants |
| Sex: Female, Male Male | 35 Participants | 42 Participants | 77 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 15 / 56 | 17 / 54 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Need for an Endotracheal Intubation Within Seven Days After Onset of Cardiopulmonary Edema at the Intensive Care Unit
Time frame: Whitin seven days after onset of cardiopulmonary edema at the Intensive Care Unit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Non-Invasive Ventilation (NIV Group) | Need for an Endotracheal Intubation Within Seven Days After Onset of Cardiopulmonary Edema at the Intensive Care Unit | 5 Participants |
| Continuous Positive Airway Pressure (CPAP) Group | Need for an Endotracheal Intubation Within Seven Days After Onset of Cardiopulmonary Edema at the Intensive Care Unit | 5 Participants |
Comparison: 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%).p-value: 1Chi-squared
Secondary
28th Day Mortality
Mortility of patients within of the first 28 days after randomization (either at intensive car unit or at hospital)
Time frame: Mortality within 28 days of randomization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Non-Invasive Ventilation (NIV Group) | 28th Day Mortality | 13 Participants |
| Continuous Positive Airway Pressure (CPAP) Group | 28th Day Mortality | 16 Participants |
Secondary
Acute Renal Failure
Development of acute renal failure measured as increase of level of creatinine
Time frame: Acute Renal Failure during intensive care unit stay (at discharge from intensive care unit)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Non-Invasive Ventilation (NIV Group) | Acute Renal Failure | 12 Participants |
| Continuous Positive Airway Pressure (CPAP) Group | Acute Renal Failure | 13 Participants |
Secondary
Duration of the Ventilation
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: Time (hours) from start of ventilation until the removal of both devices because of improve or failure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Non-Invasive Ventilation (NIV Group) | Duration of the Ventilation | 16 hours |
| Continuous Positive Airway Pressure (CPAP) Group | Duration of the Ventilation | 10 hours |
Secondary
Hospital Mortality
Mortality during hospital stay (including at Intensive care mortality)
Time frame: Mortality (%) at Hospital at discharge from hospital
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Non-Invasive Ventilation (NIV Group) | Hospital Mortality | 15 Participants |
| Continuous Positive Airway Pressure (CPAP) Group | Hospital Mortality | 17 Participants |
Secondary
Intensive Care Unit Mortality
Mortality (%) at Intensive Care Unit
Time frame: Mortality (%) at Intensive Care Unit at discharge from intensive care unit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Non-Invasive Ventilation (NIV Group) | Intensive Care Unit Mortality | 12 Participants |
| Continuous Positive Airway Pressure (CPAP) Group | Intensive Care Unit Mortality | 14 Participants |
Secondary
Length of Hospital Stay
All the time (days) the patient stays at the hospital
Time frame: Length of stay (days) at hospital at discharge from hospital
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Non-Invasive Ventilation (NIV Group) | Length of Hospital Stay | 12 days |
| Continuous Positive Airway Pressure (CPAP) Group | Length of Hospital Stay | 14 days |
Secondary
Length of Stay at Intensive Care Unit
Length of stay of the patient at Intensive Care Unit
Time frame: Length of stay (days) at Intensive Care Unit at discharge from intensive care unit.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Non-Invasive Ventilation (NIV Group) | Length of Stay at Intensive Care Unit | 3 days |
| Continuous Positive Airway Pressure (CPAP) Group | Length of Stay at Intensive Care Unit | 4 days |
Secondary
Ventilator Acquired Pneumonia
Pulmonary infections (%) during stay at intensive care unit
Time frame: Pulmonary infection at intensive care unit diagnosed until 72 hours after removal of ventilation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Non-Invasive Ventilation (NIV Group) | Ventilator Acquired Pneumonia | 3 Participants |
| Continuous Positive Airway Pressure (CPAP) Group | Ventilator Acquired Pneumonia | 1 Participants |