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

This study has been completed.
Sponsor:
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT00529347
First received: September 12, 2007
Last updated: September 7, 2009
Last verified: September 2009
  Purpose

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 Intervention Phase
Mechanical Ventilation
Device: neurally adjusted ventilatory assist (NAVA)
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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)

Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • Change in diaphragmatic Edi (area under the curve) during expiration [ Time Frame: At each intervention ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: September 2007
Study Completion Date: July 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: neurally adjusted ventilatory assist (NAVA)
    assessment of breathing pattern at various ventilator settings
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00529347

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

Publications:
Responsible Party: Lukas Brander, MD, University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT00529347     History of Changes
Other Study ID Numbers: SNF-3200B0-113478-1
Study First Received: September 12, 2007
Last Updated: September 7, 2009
Health Authority: Switzerland: Ethikkommission

ClinicalTrials.gov processed this record on October 23, 2014