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Effects of NAVA and PSV to AECOPD Patients' Air Distribution and Dead Space

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
NAVA and PSV
Sponsored by
Southeast University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • AECOPD patients who need invasive mechanical ventilation
  • Patients who can tolerate assist mechanical ventilation
  • Patients who have signed ICF

Exclusion Criteria:

  • Patients who are younger than 18 years old or older than 75 years old
  • Patients whose respiratory center is severely inhibited
  • Patients who can not stand NAVA gastric tube
  • Patients who have coagulation disorders
  • Patients whose vital signs are unstable
  • Patients who are in other clinical trails

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    neurally adjusted ventilatory assist

    pressure support ventilation

    Arm Description

    Outcomes

    Primary Outcome Measures

    the ratio of physiologic dead space over tidal volume (VD/VT)

    Secondary Outcome Measures

    Full Information

    First Posted
    October 16, 2014
    Last Updated
    November 12, 2014
    Sponsor
    Southeast University, China
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02289573
    Brief Title
    Effects of NAVA and PSV to AECOPD Patients' Air Distribution and Dead Space
    Official Title
    Effects of NAVA and PSV to AECOPD Patients' Air Distribution and Dead Space
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2014
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2014 (undefined)
    Primary Completion Date
    June 2015 (Anticipated)
    Study Completion Date
    June 2015 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Southeast University, China

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Chronic obstructive pulmonary disease(COPD) is a common disease among people. Acute exacerbation of chronic obstructive pulmonary disease(AECOPD) is the acute and aggravating phase of COPD which may lead to respiratory failure. Mechanical ventilation is a very important therapy for those patients,but traditional ventilation modes have some defects, so investigators need to find new modes to solve these problems. In this study, the investigators compare neurally adjusted ventilatory assist (NAVA) and PSV to observe the effects on AECOPD patients' air distribution and dead space to determine if NAVA is a more appropriate ventilation mode for AECOPD patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Obstructive Pulmonary Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    15 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    neurally adjusted ventilatory assist
    Arm Type
    Experimental
    Arm Title
    pressure support ventilation
    Arm Type
    Sham Comparator
    Intervention Type
    Device
    Intervention Name(s)
    NAVA and PSV
    Intervention Description
    change ventilation modes(NAVA and PSV) with different support levels
    Primary Outcome Measure Information:
    Title
    the ratio of physiologic dead space over tidal volume (VD/VT)
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: AECOPD patients who need invasive mechanical ventilation Patients who can tolerate assist mechanical ventilation Patients who have signed ICF Exclusion Criteria: Patients who are younger than 18 years old or older than 75 years old Patients whose respiratory center is severely inhibited Patients who can not stand NAVA gastric tube Patients who have coagulation disorders Patients whose vital signs are unstable Patients who are in other clinical trails

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    28578708
    Citation
    Sun Q, Liu L, Pan C, Zhao Z, Xu J, Liu A, Qiu H. Effects of neurally adjusted ventilatory assist on air distribution and dead space in patients with acute exacerbation of chronic obstructive pulmonary disease. Crit Care. 2017 Jun 2;21(1):126. doi: 10.1186/s13054-017-1714-1.
    Results Reference
    derived

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    Effects of NAVA and PSV to AECOPD Patients' Air Distribution and Dead Space

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