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Non-invasive Neurally Adjusted Ventilatory Assist

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University Hospital Inselspital, Berne.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Lukas Brander, MD, University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT01280383
First received: January 10, 2011
Last updated: June 25, 2012
Last verified: June 2012

January 10, 2011
June 25, 2012
November 2010
December 2013   (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, Lindstrom L. Neural control of mechanical ventilation in respiratory failure. Nat Med. 1999 Dec;5(12):1433-6. Review. No abstract available.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
December 2013
December 2013   (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
No
Contact: Lukas Brander, MD ++41 41 205 4909 lukas.brander@bluewin.ch
Switzerland
 
NCT01280383
BE KEK 123/10
No
Lukas Brander, MD, 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
June 2012

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