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This study has been withdrawn prior to enrollment.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

January 10, 2011
July 22, 2015
November 2010
May 2015   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01280383 on ClinicalTrials.gov Archive Site
changes in respiratory pattern [ Time Frame: study duration ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Non-invasive Neurally Adjusted Ventilatory Assist
Non-invasive Neurally Adjusted Ventilatory Assist (niNAVA) After Extubation: Proposal for a Crossover-randomized Feasibility Trial
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.
To assess the effects of non-invasive NAVA on respiratory muscle unloading in critically ill patients
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Respiratory Failure
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
Experimental: non-invasive NAVA
application of non-invasive NAVA in critically ill patients
Intervention: Device: non-invasive neurally adjusted ventilatory assist
Sinderby C, Navalesi P, Beck J, Skrobik Y, Comtois N, Friberg S, Gottfried SB, Lindström L. Neural control of mechanical ventilation in respiratory failure. Nat Med. 1999 Dec;5(12):1433-6. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
May 2015
May 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Switzerland
 
NCT01280383
BE KEK 123/10
No
Not Provided
Not Provided
University Hospital Inselspital, Berne
University Hospital Inselspital, Berne
Not Provided
Principal Investigator: Lukas Brander, MD University Hospital (Inselspital) and University of Bern
University Hospital Inselspital, Berne
July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP