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Assist Control Versus Pressure Support Modes for Domiciliary Noninvasive Ventilation in Chronic Respiratory Failure

Primary Purpose

Chronic Respiratory Failure

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
respiratory settings
Sponsored by
Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Respiratory Failure

Eligibility Criteria

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

Inclusion Criteria: Chronic respiratory failure Clinical symptoms of chronic alveolar hypoventilation PaCO2 ≥ 45 mmHg in case of restrictive pulmonary disorder or PaCO2 ≥ 55 mmHg in case or obstructive pulmonary disorder Exclusion Criteria: Clinical exacerbation during the three previous weeks Previous treatment by domiciliary non invasive ventilation Previous treatment by non invasive ventilation for acute respiratory failure during the 3 previous months Bronchiectasis Duchenne muscular dystrophy Amyotrophic lateral sclerosis

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    respiratory support

    Assist Control

    Arm Description

    a mode of ventilation in comparison

    an other mode of ventilation in comparison

    Outcomes

    Primary Outcome Measures

    PaO2
    Blood gases response to ventilation

    Secondary Outcome Measures

    Full Information

    First Posted
    September 12, 2005
    Last Updated
    February 16, 2011
    Sponsor
    Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00189527
    Brief Title
    Assist Control Versus Pressure Support Modes for Domiciliary Noninvasive Ventilation in Chronic Respiratory Failure
    Official Title
    Assist Control Versus Pressure Support Modes for Domiciliary Noninvasive Ventilation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2006 (undefined)
    Primary Completion Date
    June 2009 (Actual)
    Study Completion Date
    October 2009 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Noninvasive ventilation is a therapeutic option in some patients with chronic respiratory failure. Patients usually ventilate during nightime with a domiciliary ventilator either in assist control or in pressure support mode. The aim of this study is to compare the clinical efficacy and the tolerance of assist control and pressure support modes during domiciliary noninvasive ventilation in patients with chronic respiratory failure.
    Detailed Description
    The aim of this study is to compare the clinical efficacy and the tolerance of assist control and pressure support modes during domiciliary noninvasive ventilation in patients with chronic respiratory failure.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Respiratory Failure

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    respiratory support
    Arm Type
    Experimental
    Arm Description
    a mode of ventilation in comparison
    Arm Title
    Assist Control
    Arm Type
    Active Comparator
    Arm Description
    an other mode of ventilation in comparison
    Intervention Type
    Procedure
    Intervention Name(s)
    respiratory settings
    Primary Outcome Measure Information:
    Title
    PaO2
    Description
    Blood gases response to ventilation
    Time Frame
    months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Chronic respiratory failure Clinical symptoms of chronic alveolar hypoventilation PaCO2 ≥ 45 mmHg in case of restrictive pulmonary disorder or PaCO2 ≥ 55 mmHg in case or obstructive pulmonary disorder Exclusion Criteria: Clinical exacerbation during the three previous weeks Previous treatment by domiciliary non invasive ventilation Previous treatment by non invasive ventilation for acute respiratory failure during the 3 previous months Bronchiectasis Duchenne muscular dystrophy Amyotrophic lateral sclerosis
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Antoine CUVELIER, MD, PhD
    Organizational Affiliation
    Rouen University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Assist Control Versus Pressure Support Modes for Domiciliary Noninvasive Ventilation in Chronic Respiratory Failure

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