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

Primary Purpose

Cardiogenic Pulmonary Oedema

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Non-Invasive Ventilation
Continuous Positive AirwayPressure CPAP
Sponsored by
Hospital General Universitario de Castellón
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiogenic Pulmonary Oedema focused on measuring Non-invasive ventilation,, continuous positive airway pressure, cardiogenic pulmonary oedema,, acute respiratory failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Non-Invasive ventilation (NIV group)

    Continuous Positive AirwayPressure CPAP

    Arm Description

    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.

    The CPAP was applied by using a flow generator with adjustable fractional inspired oxygen (FiO2). 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 virtual valve. A initial level of 5cmH20 of PEEP was recommended for the first hour of ventilation, 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 it was replaced by a Venturi mask.

    Outcomes

    Primary Outcome Measures

    Need for an Endotracheal Intubation Within Seven Days After Onset of Cardiopulmonary Edema at the Intensive Care Unit

    Secondary Outcome Measures

    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
    Ventilator Acquired Pneumonia
    Pulmonary infections (%) during stay at intensive care unit
    Acute Renal Failure
    Development of acute renal failure measured as increase of level of creatinine
    Length of Stay at Intensive Care Unit
    Length of stay of the patient at Intensive Care Unit
    Length of Hospital Stay
    All the time (days) the patient stays at the hospital
    Intensive Care Unit Mortality
    Mortality (%) at Intensive Care Unit
    28th Day Mortality
    Mortility of patients within of the first 28 days after randomization (either at intensive car unit or at hospital)
    Hospital Mortality
    Mortality during hospital stay (including at Intensive care mortality)

    Full Information

    First Posted
    November 21, 2016
    Last Updated
    June 22, 2017
    Sponsor
    Hospital General Universitario de Castellón
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02977572
    Brief Title
    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

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2007 (undefined)
    Primary Completion Date
    December 2010 (Actual)
    Study Completion Date
    January 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital General Universitario de Castellón

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiogenic Pulmonary Oedema
    Keywords
    Non-invasive ventilation,, continuous positive airway pressure, cardiogenic pulmonary oedema,, acute respiratory failure

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    114 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Non-Invasive ventilation (NIV group)
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Continuous Positive AirwayPressure CPAP
    Arm Type
    Placebo Comparator
    Arm Description
    The CPAP was applied by using a flow generator with adjustable fractional inspired oxygen (FiO2). 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 virtual valve. A initial level of 5cmH20 of PEEP was recommended for the first hour of ventilation, 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 it was replaced by a Venturi mask.
    Intervention Type
    Device
    Intervention Name(s)
    Non-Invasive Ventilation
    Intervention Description
    In arm description
    Intervention Type
    Device
    Intervention Name(s)
    Continuous Positive AirwayPressure CPAP
    Intervention Description
    In arm description
    Primary Outcome Measure Information:
    Title
    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
    Secondary Outcome Measure Information:
    Title
    Duration of the Ventilation
    Description
    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
    Title
    Ventilator Acquired Pneumonia
    Description
    Pulmonary infections (%) during stay at intensive care unit
    Time Frame
    Pulmonary infection at intensive care unit diagnosed until 72 hours after removal of ventilation
    Title
    Acute Renal Failure
    Description
    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)
    Title
    Length of Stay at Intensive Care Unit
    Description
    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.
    Title
    Length of Hospital Stay
    Description
    All the time (days) the patient stays at the hospital
    Time Frame
    Length of stay (days) at hospital at discharge from hospital
    Title
    Intensive Care Unit Mortality
    Description
    Mortality (%) at Intensive Care Unit
    Time Frame
    Mortality (%) at Intensive Care Unit at discharge from intensive care unit
    Title
    28th Day Mortality
    Description
    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
    Title
    Hospital Mortality
    Description
    Mortality during hospital stay (including at Intensive care mortality)
    Time Frame
    Mortality (%) at Hospital at discharge from hospital

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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).
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    ALBERTO BELENGUER-MUNCHARAZ, MD
    Organizational Affiliation
    INTENSIVE CARE UNIT. HOSPITAL GENERAL CASTELLO
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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