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.
Information provided by:
University Hospital Inselspital, Berne
First received: September 12, 2007
Last updated: September 7, 2009
Last verified: September 2009
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.
Device: neurally adjusted ventilatory assist (NAVA)
||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
||The Effect of Positive End Expiratory Pressure (PEEP) on the Breathing Pattern During Neurally Adjusted Ventilatory Assist (NAVA)
Primary Outcome Measures:
- Change in diaphragmatic Edi (area under the curve) during expiration [ Time Frame: At each intervention ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||January 2009 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years to 85 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00529347
|Department of Intensive Care Medicine, University Hospital - Inselspital
|Bern, Switzerland, 3010 |
University Hospital Inselspital, Berne
||Lukas Brander, MD
||Department of Intensive Care Medicine, University Hospital, Bern, Switzerland
ClinicalTrials.gov processed this record on August 28, 2014
||Lukas Brander, MD, University Hospital Inselspital, Berne
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 12, 2007
||September 7, 2009