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
  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

Resource links provided by NLM:


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 ]

Estimated Enrollment: 10
Study Start Date: November 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01280383

Contacts
Contact: Lukas Brander, MD ++41 41 205 4909 lukas.brander@bluewin.ch

Locations
Switzerland
Department of Intensive Care Medicine, University Hospital - Inselspital, Bern Recruiting
Bern, Switzerland, 3010
Contact: Lukas Brander, MD    ++41 31 205 4909    lukas.brander@bluewin.ch   
Principal Investigator: Lukas Brander, MD         
Sub-Investigator: David Berger, MD         
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: Lukas Brander, MD, PD Dr med Lukas Brander, 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: June 25, 2012
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 October 21, 2014