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Mechanical Ventilation Controlled by the Electrical Activity of the Patient's Diaphragm - Effects of Changes in Ventilator Parameters on Breathing Pattern

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ClinicalTrials.gov Identifier: NCT00529347
Recruitment Status : Completed
First Posted : September 14, 2007
Last Update Posted : September 9, 2009
Information provided by:
University Hospital Inselspital, Berne

Brief Summary:
Neurally adjusted ventilatory assist (NAVA) is a new concept of mechanical ventilation. NAVA delivers assist to spontaneous breathing based on the detection of the electrical activity of the diaphragm. We study the effect of changing ventilatory parameters on the patient's breathing pattern during NAVA.

Condition or disease Intervention/treatment Phase
Mechanical Ventilation Device: neurally adjusted ventilatory assist (NAVA) Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Effect of Positive End Expiratory Pressure (PEEP) on the Breathing Pattern During Neurally Adjusted Ventilatory Assist (NAVA)
Study Start Date : September 2007
Primary Completion Date : January 2009
Study Completion Date : July 2009

Intervention Details:
    Device: neurally adjusted ventilatory assist (NAVA)
    assessment of breathing pattern at various ventilator settings

Primary Outcome Measures :
  1. Change in diaphragmatic Edi (area under the curve) during expiration [ Time Frame: At each intervention ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Invasive mechanical ventilation (tracheally intubated or tracheotomized)
  • Presence of an arterial pressure line.
  • Subject itself or its next of kin has given written informed consent

Exclusion Criteria:

  • Patient is less than 18 years or more than 85 years of age
  • The attending physician refuses to allow enrollment
  • The patient refuses informed consent
  • Next of kin is unavailable or refuses informed consent
  • Pregnant or breast-feeding female. A pregnancy test will be performed in all female patients less than 60 years of age.
  • Any contraindication to insertion/exchange a nasogastric tube, including (but not limited to): severe oropharyngeal malformation or bleeding; esophageal varices, tumor, infection, stenosis, or rupture
  • Presence or suspicion of diaphragm injury
  • Hemophilia or other severe bleeding disorder
  • Presence or suspicion of a central nervous system (CNS) disorder, including (but not limited to): CNS infarction, bleeding, tumor, or infection
  • History of heart and/or lung transplantation
  • Any mechanical cardiac assist device (excluding intraaortic balloon pump)
  • Any contraindication to reduce sedation or to stop neuromuscular blockage in order to allow spontaneous breathing
  • The patient needs to be ventilated with a mode of mechanical ventilation that targets a predefined tidal volume or airway pressure as per attending physician
  • Severe hemodynamic instability as per attending physician
  • Planned or anticipated intervention within the study period necessitating either transfer out of the ICU or requiring prolonged interaction with the patient.
  • A fraction of inspired oxygen (FiO2) of > 0.8
  • The patient currently participates in another interventional clinical trial

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 ClinicalTrials.gov identifier (NCT number): NCT00529347

Department of Intensive Care Medicine, University Hospital - Inselspital
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Principal Investigator: Lukas Brander, MD Department of Intensive Care Medicine, University Hospital, Bern, Switzerland