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CO2 Clearance During Noninvasive Ventilation (NIV)

Primary Purpose

Acute Hypercapnic Respiratory Failure

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
DiMax Zero Total face mask "R",
traditional face mask
Sponsored by
IRCCS Azienda Ospedaliero-Universitaria di Bologna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Hypercapnic Respiratory Failure

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • COPD diagnosis
  • sign inform consent
  • able to tolerate the application of NIV

Exclusion Criteria:

  • inability to tolerate the mask
  • contraindication to NIV
  • cancer, neurological diseases, and need of another life support besides the ventilator

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    mask plus CO2 removal device

    traditional face mask

    Arm Description

    a "traditional" mask with inserted a new CO2 removal device that is called DiMax Zero Total face mask "R",

    Traditional mask without a CO2 clearance device inserted

    Outcomes

    Primary Outcome Measures

    changes in arterial blood gases (ABGs)
    Recording of carbon dioxide arterial tensione and oxygen arterial tension using an arterial puncture performed in the radial artery
    patient's tolerance to the mask
    the tolerance will be recorded using an ad hoc scale

    Secondary Outcome Measures

    Full Information

    First Posted
    November 23, 2018
    Last Updated
    November 26, 2018
    Sponsor
    IRCCS Azienda Ospedaliero-Universitaria di Bologna
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03756415
    Brief Title
    CO2 Clearance During Noninvasive Ventilation (NIV)
    Official Title
    Evaluation of a New System to Clear CO2 During Noninvasive Ventilation (NIV)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 1, 2019 (Anticipated)
    Primary Completion Date
    June 1, 2019 (Anticipated)
    Study Completion Date
    June 1, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    IRCCS Azienda Ospedaliero-Universitaria di Bologna

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    In this randomized cross over study the investigators will evaluate the effects on gas exchange and patients' tolerance of a new CO2 non rebreathing devices incorporated in the mask vs the traditional mask COPD patients undergoing NIV for an episode of Acute Hypercapnia Respiratory Failure, will be randomized after at least 12 hour of ventilation to 1 h.trial with the usual full face mask or the same mask with the addition of a new CO2 clearance device
    Detailed Description
    In this randomized cross over study the investigators will evaluate the effects on gas exchange and patients' tolerance of a new CO2 non rebreathing devices incorporated in the mask vs the traditional mask COPD patients undergoing NIV for an episode of Acute Hypercapnia Respiratory Failure, will be randomized after at least 12 hour of ventilation to 1 h.trial with the usual full face mask (FM) or the same mask with the addition of a new CO2 clearance device (FM+d) In the interval between NIV sessions, arterial blood gases will be monitored and if PaCO2 will return to a baseline value with a tolerance of 10%, the patients will undergo another 1 h trial using the other mask. The subjects will be studied in the sitting position and asked to relax throughout the period of the study. The patients will be ventilated using pressure support ventilation (PSV) The order of use of the two interfaces will be determined for each patient by a previously generated randomized sequence. FIO2 will be adjusted to obtain oxygen saturation around 92% at baseline and never modified throughout the study. End-expiratory pressure will always fixed at 2 cm H2O, and trigger sensitivity will set at -0.5 cm H2O. Inspiratory assistance during either PSV will be titrated to achieve a tidal volume between 6-8 mL/kg while avoiding occurrence of discomfort or visually assessed "wasted efforts". The ventilatory settings will determined at the beginning of the first trial, and maintained unmodified throughout all the 3 runs. Patient tolerance to NIMV, defined as the level of comfort using the different mask, will be assessed by means of a scale used and validated in previous studies that is defined as follows: 1, bad; 2, poor; 3, sufficient; 4, good; 5, very good. The patients were asked by the respiratory therapist to answer the following question: "How do the patient feel your breathing is using this mask?" The patient will give the score to the therapist at the end of each run, just before ABG measurements.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    mask plus CO2 removal device
    Arm Type
    Experimental
    Arm Description
    a "traditional" mask with inserted a new CO2 removal device that is called DiMax Zero Total face mask "R",
    Arm Title
    traditional face mask
    Arm Type
    Active Comparator
    Arm Description
    Traditional mask without a CO2 clearance device inserted
    Intervention Type
    Device
    Intervention Name(s)
    DiMax Zero Total face mask "R",
    Intervention Description
    a non-CO2 rebreathing device included directly in the full face mask
    Intervention Type
    Device
    Intervention Name(s)
    traditional face mask
    Intervention Description
    a traditional mask without a non-CO2 rebreathing device included directly in the full face mask
    Primary Outcome Measure Information:
    Title
    changes in arterial blood gases (ABGs)
    Description
    Recording of carbon dioxide arterial tensione and oxygen arterial tension using an arterial puncture performed in the radial artery
    Time Frame
    immediate
    Title
    patient's tolerance to the mask
    Description
    the tolerance will be recorded using an ad hoc scale
    Time Frame
    immediate

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: COPD diagnosis sign inform consent able to tolerate the application of NIV Exclusion Criteria: inability to tolerate the mask contraindication to NIV cancer, neurological diseases, and need of another life support besides the ventilator
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    stefano nava
    Phone
    3333751828
    Email
    stefanava@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    vittoria comellini
    Email
    vittoria.comellini@aosp.bo.it
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    stefano nava
    Organizational Affiliation
    Azienda Ospedaliera Sant'Orsola
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    not allow to release individual data

    Learn more about this trial

    CO2 Clearance During Noninvasive Ventilation (NIV)

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