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Use of the Medical Device DECAP CO2 for the Treatment of Hypercapnic Respiratory Distress in Patients Under Noninvasive Ventilation (DECAP CO2)

Primary Purpose

Respiratory Distress Syndrome, Hypercapnia

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Extracorporeal CO2 removal device
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Distress Syndrome focused on measuring Hypercapnia, Respiratory Distress Syndrome, Extracorporeal CO2 remover, Noninvasive ventilation

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Adult patient suffering from severe chronic respiratory failure

  • Chronic obstructive pulmonary disease : stage III
  • Hypercapnic respiratory decomposition
  • No anticipated directive with the treating physician, pulmonologist or his family.
  • Challenged for invasive ventilation by critical care doctor, emergency doctor or pulmonologist ; due to the respiratory pathology severity or other (age, comorbidity)
  • Not challenged for a noninvasive ventilation
  • Failure of the noninvasive ventilation in intensive care unit (pH decrease due to hypercapnia after 2 hours of noninvasive ventilation

Obtaining of the consent of the patient or the reliable person or the close relation

Exclusion Criteria:

  • - Patients who made anticipated directives (decision of the patient to have no tracheotomy, intubation, noninvasive ventilation)
  • Contraindication to heparin (active bleeding, Heparin-induced thrombocytopenia)
  • Patients < 18 years and > 90 years
  • Patients already included in another therapeutic trial
  • Pregnant woman or breast feeding
  • Legal incapacity

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    noninvasive ventilation alone

    noninvasive ventilation associated with the DECAP CO2 device

    Arm Description

    After validation of the inclusion and exclusion criteria, the patients include in this clinical trial will be randomized between the two arms of the study: Noninvasive ventilation alone Noninvasive ventilation associated with the DECAP CO2 device

    After validation of the inclusion and exclusion criteria, the patients include in this clinical trial will be randomized between the two arms of the study: Noninvasive ventilation alone Noninvasive ventilation associated with the DECAP CO2 device

    Outcomes

    Primary Outcome Measures

    Hypercapnia

    Secondary Outcome Measures

    Blood gases
    Duration of judgment disability
    Duration of blood pH normalization
    Duration of hypercapnia
    Glasgow
    SAPSII scores(Simplified Acute Physiology Score II)
    Duration of noninvasive ventilation
    Duration of hospitalization
    Mortality
    MMSE (Mini Mental State Examination)
    ACE ( Aid To Capacity Evaluation)scores
    SOFA scores(Sepsis-related Organ )
    Blood gases
    Blood gases
    Blood gases
    Blood gases
    Blood gases
    Blood gases
    Blood gases
    Blood Gases
    Blood gases
    Blood gases
    Blood gases
    Blood gases
    Blood gases
    Blood gases
    Glasgow
    Glasgow
    Glasgow
    Glasgow
    Glasgow
    MMSE (Mini Mental State Examination)
    MMSE (Mini Mental State Examination)
    MMSE (Mini Mental State Examination)
    MMSE (Mini Mental State Examination)
    MMSE (Mini Mental State Examination)
    ACE ( Aid To Capacity Evaluation)scores
    ACE ( Aid To Capacity Evaluation)scores
    ACE ( Aid To Capacity Evaluation)scores
    ACE ( Aid To Capacity Evaluation)scores
    ACE ( Aid To Capacity Evaluation)scores

    Full Information

    First Posted
    January 7, 2013
    Last Updated
    January 21, 2013
    Sponsor
    University Hospital, Clermont-Ferrand
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01774422
    Brief Title
    Use of the Medical Device DECAP CO2 for the Treatment of Hypercapnic Respiratory Distress in Patients Under Noninvasive Ventilation
    Acronym
    DECAP CO2
    Official Title
    Use of the Medical Device DECAP CO2 for the Treatment of Hypercapnic Respiratory Distress in Patients Under Noninvasive Ventilation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2013
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2013 (undefined)
    Primary Completion Date
    January 2015 (Anticipated)
    Study Completion Date
    January 2015 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Clermont-Ferrand

    4. Oversight

    5. Study Description

    Brief Summary
    The patients affected by severe chronic respiratory failure can develop hypercapnic decompensation leading to coma and death in a few hours. At present, the main treatment is noninvasive or invasive ventilation. The noninvasive invasive ventilation requires a minimum of consciousness to insure spontaneous ventilation. In case of noninvasive ventilation impossibility, invasive mechanical ventilation is proposed to patients, which is an aggressive therapy. Regularly, the patients undergo this aggressive therapy without having expressed their opinion. Indeed, a great majority of these patients with severe respiratory insufficiency did not anticipate directives in case of respiratory decompensation (acceptation of aggressive treatments). Efficiency of these aggressive therapies is still uncertain but certainly alters quality of life (discomfort, loss of autonomy…). After complete, clear, loyal and adapted information, a majority of patient do not wish to go on these aggressive therapies. At the time of the decompensation, the patients are incapable to express an opinion because of the hypercapnic narcosis. An extracorporeal CO2 remover device, such as the DECAP CO2, would quickly decrease the hypercapnia what would allow the patient to improve his state of consciousness and so to find the conditions of spontaneous ventilation required for the noninvasive ventilation. The DECAP CO2 device can be used to stop quickly the hypercapnic narcosis and to collect the wills of the patient on the choice of possible aggressive therapies. It is in this last condition that we wish to estimate the DECAP CO2 device.
    Detailed Description
    After validation of the inclusion and exclusion criteria, the patients include in this clinical trial will be randomized between the two arms of the study: Noninvasive ventilation alone Noninvasive ventilation associated with the DECAP CO2 device

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Respiratory Distress Syndrome, Hypercapnia
    Keywords
    Hypercapnia, Respiratory Distress Syndrome, Extracorporeal CO2 remover, Noninvasive ventilation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    32 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    noninvasive ventilation alone
    Arm Type
    Experimental
    Arm Description
    After validation of the inclusion and exclusion criteria, the patients include in this clinical trial will be randomized between the two arms of the study: Noninvasive ventilation alone Noninvasive ventilation associated with the DECAP CO2 device
    Arm Title
    noninvasive ventilation associated with the DECAP CO2 device
    Arm Type
    Other
    Arm Description
    After validation of the inclusion and exclusion criteria, the patients include in this clinical trial will be randomized between the two arms of the study: Noninvasive ventilation alone Noninvasive ventilation associated with the DECAP CO2 device
    Intervention Type
    Device
    Intervention Name(s)
    Extracorporeal CO2 removal device
    Primary Outcome Measure Information:
    Title
    Hypercapnia
    Time Frame
    H24
    Secondary Outcome Measure Information:
    Title
    Blood gases
    Time Frame
    H0
    Title
    Duration of judgment disability
    Time Frame
    H72
    Title
    Duration of blood pH normalization
    Time Frame
    H72
    Title
    Duration of hypercapnia
    Time Frame
    H72
    Title
    Glasgow
    Time Frame
    H0
    Title
    SAPSII scores(Simplified Acute Physiology Score II)
    Time Frame
    H24
    Title
    Duration of noninvasive ventilation
    Time Frame
    H72
    Title
    Duration of hospitalization
    Time Frame
    H72
    Title
    Mortality
    Time Frame
    H72
    Title
    MMSE (Mini Mental State Examination)
    Time Frame
    H0
    Title
    ACE ( Aid To Capacity Evaluation)scores
    Time Frame
    H0
    Title
    SOFA scores(Sepsis-related Organ )
    Time Frame
    H24
    Title
    Blood gases
    Time Frame
    H1
    Title
    Blood gases
    Time Frame
    H2
    Title
    Blood gases
    Time Frame
    H3
    Title
    Blood gases
    Time Frame
    H4
    Title
    Blood gases
    Time Frame
    H6
    Title
    Blood gases
    Time Frame
    H12
    Title
    Blood gases
    Time Frame
    H18
    Title
    Blood Gases
    Time Frame
    H24
    Title
    Blood gases
    Time Frame
    H32
    Title
    Blood gases
    Time Frame
    H40
    Title
    Blood gases
    Time Frame
    H48
    Title
    Blood gases
    Time Frame
    H56
    Title
    Blood gases
    Time Frame
    H64
    Title
    Blood gases
    Time Frame
    H72
    Title
    Glasgow
    Time Frame
    H4
    Title
    Glasgow
    Time Frame
    H8
    Title
    Glasgow
    Time Frame
    H24
    Title
    Glasgow
    Time Frame
    H36
    Title
    Glasgow
    Time Frame
    H48
    Title
    MMSE (Mini Mental State Examination)
    Time Frame
    H4
    Title
    MMSE (Mini Mental State Examination)
    Time Frame
    H8
    Title
    MMSE (Mini Mental State Examination)
    Time Frame
    H24
    Title
    MMSE (Mini Mental State Examination)
    Time Frame
    H36
    Title
    MMSE (Mini Mental State Examination)
    Time Frame
    H48
    Title
    ACE ( Aid To Capacity Evaluation)scores
    Time Frame
    H4
    Title
    ACE ( Aid To Capacity Evaluation)scores
    Time Frame
    H8
    Title
    ACE ( Aid To Capacity Evaluation)scores
    Time Frame
    H24
    Title
    ACE ( Aid To Capacity Evaluation)scores
    Time Frame
    H36
    Title
    ACE ( Aid To Capacity Evaluation)scores
    Time Frame
    H48

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adult patient suffering from severe chronic respiratory failure Chronic obstructive pulmonary disease : stage III Hypercapnic respiratory decomposition No anticipated directive with the treating physician, pulmonologist or his family. Challenged for invasive ventilation by critical care doctor, emergency doctor or pulmonologist ; due to the respiratory pathology severity or other (age, comorbidity) Not challenged for a noninvasive ventilation Failure of the noninvasive ventilation in intensive care unit (pH decrease due to hypercapnia after 2 hours of noninvasive ventilation Obtaining of the consent of the patient or the reliable person or the close relation Exclusion Criteria: - Patients who made anticipated directives (decision of the patient to have no tracheotomy, intubation, noninvasive ventilation) Contraindication to heparin (active bleeding, Heparin-induced thrombocytopenia) Patients < 18 years and > 90 years Patients already included in another therapeutic trial Pregnant woman or breast feeding Legal incapacity
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Patrick LACARIN
    Phone
    04 73 75 11 95
    Email
    placarin@chu-clermontferrand.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Alexandre LAUTRETTE
    Organizational Affiliation
    University Hospital, Clermont-Ferrand
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Use of the Medical Device DECAP CO2 for the Treatment of Hypercapnic Respiratory Distress in Patients Under Noninvasive Ventilation

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