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Non-invasive Neurally Adjusted Ventilatory Assist

Primary Purpose

Respiratory Failure

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
non-invasive neurally adjusted ventilatory assist
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Failure focused on measuring non-invasive ventilation, diaphragm, electrical activity, neurally adjusted ventilatory assist, critically ill patients

Eligibility Criteria

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

Inclusion Criteria:

  • Age 18 - 85 years
  • History of chronic obstructive lung disease
  • Invasive mechanical ventilation for more than 12 hours
  • Planned extubation according to the weaning protocol of our clinic
  • Informed consent obtained from a next of kin
  • Enrollment approval from a neutral physician neither participating in the study nor in the clinical treatment of the patient

Exclusion Criteria:

  • Tracheostomy
  • Facial or cranial trauma or surgery
  • Oral, esophageal, diaphragmatic or gastric trauma or surgery
  • Contraindication to insertion of a nasogastric tube (e. g. malformation, esophageal varices, esophageal perforation or rupture, Zenkers diverticulum, severe bleeding disorder)
  • Uncooperative state and combativeness not responding to low levels of sedatives
  • Neurological disease possibly influencing the brainstem respiratory centre, such as but not limited to: intracerebral, subarachnoidal or subdural hemorrhage, cerebral infarction, possible hypoxic encephalopathy
  • Next of kin refuses informed consent
  • Pregnancy. In female patients between 18 and 60 years of age, a pregnancy test will be performed.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    non-invasive NAVA

    Arm Description

    application of non-invasive NAVA in critically ill patients

    Outcomes

    Primary Outcome Measures

    patient-ventilator synchrony

    Secondary Outcome Measures

    changes in respiratory pattern

    Full Information

    First Posted
    January 10, 2011
    Last Updated
    July 22, 2015
    Sponsor
    Insel Gruppe AG, University Hospital Bern
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01280383
    Brief Title
    Non-invasive Neurally Adjusted Ventilatory Assist
    Official Title
    Non-invasive Neurally Adjusted Ventilatory Assist (niNAVA) After Extubation: Proposal for a Crossover-randomized Feasibility Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2015
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Study does not meet the new legal requirements set forth in the Human Research Act
    Study Start Date
    November 2010 (undefined)
    Primary Completion Date
    May 2015 (Actual)
    Study Completion Date
    May 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Insel Gruppe AG, University Hospital Bern

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Neurally adjusted ventilatory assist (NAVA) is a new concept of mechanical ventilation. NAVA delivers assistance to spontaneous breathing based on the detection of the electrical activity of the diaphragm. The investigators will study the effects of non-invasive NAVA on respiratory muscle unloading critically ill patients.
    Detailed Description
    To assess the effects of non-invasive NAVA on respiratory muscle unloading in critically ill patients

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Respiratory Failure
    Keywords
    non-invasive ventilation, diaphragm, electrical activity, neurally adjusted ventilatory assist, critically ill patients

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    non-invasive NAVA
    Arm Type
    Experimental
    Arm Description
    application of non-invasive NAVA in critically ill patients
    Intervention Type
    Device
    Intervention Name(s)
    non-invasive neurally adjusted ventilatory assist
    Other Intervention Name(s)
    neurally adjusted ventilatory assist, non-invasive ventilation
    Intervention Description
    non-invasive neurally adjusted ventilatory assist in critically ill patients
    Primary Outcome Measure Information:
    Title
    patient-ventilator synchrony
    Time Frame
    outcomes are assessed at the end of each experimental period, i.e. every 20-30 minutes
    Secondary Outcome Measure Information:
    Title
    changes in respiratory pattern
    Time Frame
    study duration

    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: Age 18 - 85 years History of chronic obstructive lung disease Invasive mechanical ventilation for more than 12 hours Planned extubation according to the weaning protocol of our clinic Informed consent obtained from a next of kin Enrollment approval from a neutral physician neither participating in the study nor in the clinical treatment of the patient Exclusion Criteria: Tracheostomy Facial or cranial trauma or surgery Oral, esophageal, diaphragmatic or gastric trauma or surgery Contraindication to insertion of a nasogastric tube (e. g. malformation, esophageal varices, esophageal perforation or rupture, Zenkers diverticulum, severe bleeding disorder) Uncooperative state and combativeness not responding to low levels of sedatives Neurological disease possibly influencing the brainstem respiratory centre, such as but not limited to: intracerebral, subarachnoidal or subdural hemorrhage, cerebral infarction, possible hypoxic encephalopathy Next of kin refuses informed consent Pregnancy. In female patients between 18 and 60 years of age, a pregnancy test will be performed.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lukas Brander, MD
    Organizational Affiliation
    University Hospital (Inselspital) and University of Bern
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    10581089
    Citation
    Sinderby C, Navalesi P, Beck J, Skrobik Y, Comtois N, Friberg S, Gottfried SB, Lindstrom L. Neural control of mechanical ventilation in respiratory failure. Nat Med. 1999 Dec;5(12):1433-6. doi: 10.1038/71012. No abstract available.
    Results Reference
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    Non-invasive Neurally Adjusted Ventilatory Assist

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