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Non-Invasive Ventilation Versus Continuous Positive Airway Pressure in Cardiogenic Pulmonary Edema: a Multicentre Study

Primary Purpose

Cardiogenic Pulmonary Edema

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
continuous positive airway pressure
noninvasive pressure support ventilation
noninvasive pressure support ventilation
Sponsored by
University of Monastir
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiogenic Pulmonary Edema focused on measuring noninvasive ventilation, continuous posi

Eligibility Criteria

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

Inclusion Criteria:

  • All patients aged >18 years and having acute respiratory failure caused by CPE.
  • The origin of cardiogenic pulmonary edema is defined according to the history and clinical presentation, the chest X-ray and / or data of echocardiography when they are available with a serum BNP> 100pg/ml.

The acute respiratory failure is defined by the existence of clinical signs and / or arterial gas parameters:

  • sweats and / or agitation and / or signs of struggle and /or drowsiness
  • dyspnea with respiratory rate > 35/min,
  • a blood oxygen saturation ≤ 90% by air.

Exclusion Criteria:

  • Instability of the hemodynamic state (severe rhythm disturbances, hypotension with systolic arterial pressure <50 mmHg, need for inotropic drugs).
  • The need for immediate endotracheal intubation.
  • Contraindications to the use of a facial or nasal mask (or facial skin lesion).
  • History of recent gastrointestinal surgery or pseudo obstruction.
  • Refusal of participation or non-cooperation of the patient.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    continuous positive airway pressure

    NIPSV

    Arm Description

    respiratory assistance

    respiratory assistance using face mak and ventilator to provide inspiratory pressure support and positive end expiratory pressure

    Outcomes

    Primary Outcome Measures

    It is the combination of 3 events: the need for endotracheal intubation, hospital death, and ICU hospitalisation.
    Primary outcome It is the combination of 3 events: the need for endotracheal intubation, hospital death, and ICU hospitalisation.

    Secondary Outcome Measures

    The change in the rate of troponin
    The length of hospital stay

    Full Information

    First Posted
    November 4, 2008
    Last Updated
    November 4, 2008
    Sponsor
    University of Monastir
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00785174
    Brief Title
    Non-Invasive Ventilation Versus Continuous Positive Airway Pressure in Cardiogenic Pulmonary Edema: a Multicentre Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2005 (undefined)
    Primary Completion Date
    June 2008 (Actual)
    Study Completion Date
    July 2008 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of Monastir

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Non-invasive ventilation (NIV) has become now a widely used treatment modality in ICU and emergency services to deal with respiratory failure.1 NIV has the potential to improve ventilatory assistance while avoiding endotracheal intubation and its complications. Since the first publications of Meduri2 and Brochard3 the number of studies on the NIV has been growing and developing and this technique becomes one of the major progress in the field of respiratory assistance. Decompensation of chronic obstructive pulmonary disease (COPD) is certainly the least questionable indication of the NIV. However, indication of the NIV is inexorably spreading to other types of acute respiratory insufficiency, including acute cardiogenic pulmonary edema (CPE).4 Continuous positive airway pressure (CPAP) is the most currently used non-invasive ventilation usually performed without the use of a ventilator. NIV using pressure support (NIPSV) combined pressure support (inspiratory aid) and positive expiratory pressure as in CPAP. Based on physiological ground, NIPSV would be more performant than CPAP to improve ventilatory parameters and reduce the work breathing in APE. However, this issue is not settled yet. Number of meta-analysis over the last 2 years were devoted to the comparison of CPAP and NISPV,5 so that the scientific evidence is still far from established. In addition, it is not sur that patients enrolled in these studies are representative of all patients with APE. The fact that they were included solely on the basis of clinical criteria, the risk of overlap with other diagnoses is not negligible. Thus the use of markers of heart failure as the BNP (brain natriuretic peptide) would be very useful. On the other hand, the possible deleterious effect of NIPSV on myocardial perfusion is a problem that has not been definitively resolved. Objectives of the study: Compare the efficacy and safety of the NIPSV with those of CPAP in patients presenting to the emergency department with CPE. Compare the two procedures in subgroups of patients with hypercapnia and high BNP concentration.
    Detailed Description
    Cardiogenic pulmonary edema is defined as an increase of hydrostatic pressure in the pulmonary microcirculation resulting from postcapillaire hypertension. The direct consequence is extravasation of fluid in the alveolar and interstitial tissue, leading to acute hypoxemia and a decrease in lung compliance. The decrease in lung compliance, increased airway resistance (interstitial and bronchial edema) and hypoxemia will cause an increase in work of breathing. The imbalance between the ability of respiratory muscles to generate effective gas exchange and exaggerated ventilatory load can lead to respiratory muscle fatigue requiring use of mechanical ventilation through endotracheal prosthesis. In addition, the increase in inspiratory muscles work during the CPE generates very important pleural depression, which increases transmural pressure and left ventricular afterload and thus increases pulmonary edema. The CPAP is a non-invasive ventilation mode most currently used CPE. It is usually obtained via a mask and an expiratory valve to maintain constant pressure in the circuit. No inspiratory assistance is provided to the patient. The BOUSSIGNAC valve is currently used in clinical practice as an adjunct to the pharmacological treatment of CPE.The effect of CPAP is mainly linked to its ability to recruit zones that are collapsed during expiration. • NIPSV combines a positive expiratory pressure to ventilatory assistance pressure during inspiration delivered by a ventilator. It corresponds to a CPAP associated with inspiratory assistance, and thus, it is likely to improve the ventilation parameters, and in particular to reduce respiratory work more efficiently than CPAP alone.These beneficial physiological effects of NIPSV were well demonstrated during the decompensation of COPD ; they wait to be confirmed during CPE. Physiological studies have shown that the NIPSV is more effective in terms of reducing the work of breathing in CPE. However, none of the 7 published randomized studies has shown superiority of the NIPSV compared to CPAP in terms of reducing mortality and intubation requirement

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiogenic Pulmonary Edema
    Keywords
    noninvasive ventilation, continuous posi

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    200 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    continuous positive airway pressure
    Arm Type
    Active Comparator
    Arm Description
    respiratory assistance
    Arm Title
    NIPSV
    Arm Type
    Active Comparator
    Arm Description
    respiratory assistance using face mak and ventilator to provide inspiratory pressure support and positive end expiratory pressure
    Intervention Type
    Device
    Intervention Name(s)
    continuous positive airway pressure
    Other Intervention Name(s)
    Boussignac CPAP
    Intervention Description
    respiratory assistance using face mask and positive expiratory pressure apllied by a Boussignac valve
    Intervention Type
    Device
    Intervention Name(s)
    noninvasive pressure support ventilation
    Other Intervention Name(s)
    NIPSV
    Intervention Description
    noninvasive pressure support ventilation can provide inspiratory pressure support and expiratory positive pressure
    Intervention Type
    Device
    Intervention Name(s)
    noninvasive pressure support ventilation
    Other Intervention Name(s)
    NIPSV
    Intervention Description
    noninvasive pressure support ventilation provides an inspiratory aid and positive expiratory pressure using ventilator through face mask
    Primary Outcome Measure Information:
    Title
    It is the combination of 3 events: the need for endotracheal intubation, hospital death, and ICU hospitalisation.
    Time Frame
    6 hours and 30 days after protocol start
    Title
    Primary outcome It is the combination of 3 events: the need for endotracheal intubation, hospital death, and ICU hospitalisation.
    Time Frame
    6 hours and 30 days after protocol start
    Secondary Outcome Measure Information:
    Title
    The change in the rate of troponin
    Time Frame
    6 hours after protocol start
    Title
    The length of hospital stay
    Time Frame
    30 days after protocol start

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All patients aged >18 years and having acute respiratory failure caused by CPE. The origin of cardiogenic pulmonary edema is defined according to the history and clinical presentation, the chest X-ray and / or data of echocardiography when they are available with a serum BNP> 100pg/ml. The acute respiratory failure is defined by the existence of clinical signs and / or arterial gas parameters: sweats and / or agitation and / or signs of struggle and /or drowsiness dyspnea with respiratory rate > 35/min, a blood oxygen saturation ≤ 90% by air. Exclusion Criteria: Instability of the hemodynamic state (severe rhythm disturbances, hypotension with systolic arterial pressure <50 mmHg, need for inotropic drugs). The need for immediate endotracheal intubation. Contraindications to the use of a facial or nasal mask (or facial skin lesion). History of recent gastrointestinal surgery or pseudo obstruction. Refusal of participation or non-cooperation of the patient.

    12. IPD Sharing Statement

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    Non-Invasive Ventilation Versus Continuous Positive Airway Pressure in Cardiogenic Pulmonary Edema: a Multicentre Study

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