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Non-invasive Neurally Adjusted Ventilatory Assist

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01280383
Recruitment Status : Withdrawn (Study does not meet the new legal requirements set forth in the Human Research Act)
First Posted : January 20, 2011
Last Update Posted : July 23, 2015
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

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.

Condition or disease Intervention/treatment Phase
Respiratory Failure Device: non-invasive neurally adjusted ventilatory assist Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Non-invasive Neurally Adjusted Ventilatory Assist (niNAVA) After Extubation: Proposal for a Crossover-randomized Feasibility Trial
Study Start Date : November 2010
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. patient-ventilator synchrony [ Time Frame: outcomes are assessed at the end of each experimental period, i.e. every 20-30 minutes ]

Secondary Outcome Measures :
  1. changes in respiratory pattern [ Time Frame: study duration ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01280383

Sponsors and Collaborators
University Hospital Inselspital, Berne
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Principal Investigator: Lukas Brander, MD University Hospital (Inselspital) and University of Bern
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Responsible Party: University Hospital Inselspital, Berne Identifier: NCT01280383    
Other Study ID Numbers: BE KEK 123/10
First Posted: January 20, 2011    Key Record Dates
Last Update Posted: July 23, 2015
Last Verified: July 2015
Keywords provided by University Hospital Inselspital, Berne:
non-invasive ventilation
electrical activity
neurally adjusted ventilatory assist
critically ill patients
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases