Non-invasive Neurally Adjusted Ventilatory Assist

This study has been withdrawn prior to enrollment.
(Study does not meet the new legal requirements set forth in the Human Research Act)
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT01280383
First received: January 10, 2011
Last updated: July 22, 2015
Last verified: July 2015
  Purpose

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.


Condition Intervention Phase
Respiratory Failure
Device: non-invasive neurally adjusted ventilatory assist
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Non-invasive Neurally Adjusted Ventilatory Assist (niNAVA) After Extubation: Proposal for a Crossover-randomized Feasibility Trial

Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • patient-ventilator synchrony [ Time Frame: outcomes are assessed at the end of each experimental period, i.e. every 20-30 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • changes in respiratory pattern [ Time Frame: study duration ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: November 2010
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: non-invasive NAVA
application of non-invasive NAVA in critically ill patients
Device: non-invasive neurally adjusted ventilatory assist
non-invasive neurally adjusted ventilatory assist in critically ill patients
Other Names:
  • neurally adjusted ventilatory assist
  • non-invasive ventilation

Detailed Description:

To assess the effects of non-invasive NAVA on respiratory muscle unloading in critically ill patients

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01280383

Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
Principal Investigator: Lukas Brander, MD University Hospital (Inselspital) and University of Bern
  More Information

Publications:
Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT01280383     History of Changes
Other Study ID Numbers: BE KEK 123/10
Study First Received: January 10, 2011
Last Updated: July 22, 2015
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital Inselspital, Berne:
non-invasive ventilation
diaphragm
electrical activity
neurally adjusted ventilatory assist
critically ill patients

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 02, 2015