Mechanical Ventilation Controlled by the Electrical Activity of the Patient's Diaphragm - Effects on Cardiac Performance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00647361
Recruitment Status : Completed
First Posted : March 31, 2008
Last Update Posted : July 19, 2011
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 NAVA on cardiac performance in critically ill, mechanically ventilated patients.

Condition or disease Intervention/treatment Phase
Respiratory Failure Cardiac Failure Device: Neurally adjusted ventilatory assist (NAVA) provided by a commercially available mechanical ventilator (Servo i, Maquet Critical Care, Solna, Sweden). Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Short Term Effects of Neurally Adjusted Ventilatory Assist and Pressure Support Ventilation on Cardiac Performance
Study Start Date : March 2008
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Arm Intervention/treatment
Experimental: NAVA Device: Neurally adjusted ventilatory assist (NAVA) provided by a commercially available mechanical ventilator (Servo i, Maquet Critical Care, Solna, Sweden).
Neurally adjusted ventilatory assist (NAVA) and pressure support ventilation (PSV)

Primary Outcome Measures :
  1. Cardiac stroke volume index. [ Time Frame: end of experimental periods ]

Secondary Outcome Measures :
  1. Global delivery of oxygen [ Time Frame: end of experimental period ]

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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:

  1. Male or female patients aged 18 - 85 years (extremes included)
  2. Mechanical ventilation (tracheally intubated or tracheotomized)
  3. Relevant interaction between the ventilator and the cardiac performance defined as an inspiratory deflection in central venous pressure or pulmonary diastolic pressure of ≥ 5 mmHg

    1. in 10 patients with impaired cardiac performance defined as either

      • a left ventricular ejection fraction of < 40% and/or
      • treatment with dobutamine ≥2μg/kg/min, or adrenaline ≥ 3μg/kg/min and/or
      • a cardiac index of ≤ 2.2 L•min-1•m2 and/or
      • a pulmonary artery occlusion pressure (PAOP) ≥ 18 mmHg
    2. in 10 patients with a history of chronic obstructive pulmonary disease (COPD) and delayed triggering-ON / cycling-OFF and/or evidence for wasted inspiratory efforts as evidenced by:

      • limitation of expiratory air flow and intrinsic PEEP as assessed by observation of the expiratory air flow curve and measurement of the airway pressure during an expiratory hold maneuver and/or
      • excessive activation of inspiratory and / or expiratory muscles as assessed by observation of the patient
  4. Presence of a pulmonary artery catheter and an arterial pressure line
  5. Subject itself or its next of kin has given written informed consent

Exclusion Criteria:

  1. Patient is less than 18 years or more than 80 years of age
  2. The attending physician refuses to allow enrollment
  3. The patient refuses informed consent
  4. Next of kin is unavailable or refuses informed consent
  5. Pregnant or breast-feeding female. A pregnancy test will be performed in all female patients less than 60 years of age. The patient will not be enrolled in the study if the test result is positive.
  6. 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
  7. Presence or suspicion of diaphragm injury
  8. Hemophilia or other severe bleeding disorder
  9. Presence or suspicion of a central nervous system (CNS) disorder, including (but not limited to): CNS infarction, bleeding, tumor, or infection
  10. History of heart and/or lung transplantation
  11. Any mechanical cardiac assist device (including intraaortic balloon pump)
  12. Any contraindication to reduce sedation or to stop neuromuscular blockage in order to allow spontaneous breathing
  13. The patient needs to be ventilated with a mode of MV controlling for tidal volume or for airway pressure as per attending physician.
  14. Severe hemodynamic instability as judged by the attending physician
  15. Planned or anticipated intervention within the study period necessitating either transfer out of the ICU or requiring prolonged interaction with the patient.
  16. a fraction of inspired oxygen (FiO2) of > 0.8
  17. 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 identifier (NCT number): NCT00647361

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Lukas Brander, MD, University Hospital - Inselspital Identifier: NCT00647361     History of Changes
Other Study ID Numbers: KEK BE 217-06
First Posted: March 31, 2008    Key Record Dates
Last Update Posted: July 19, 2011
Last Verified: July 2011

Keywords provided by University Hospital Inselspital, Berne:
respiratory insufficiency
mechanical ventilation

Additional relevant MeSH terms:
Respiratory Insufficiency
Heart Failure
Respiration Disorders
Respiratory Tract Diseases
Heart Diseases
Cardiovascular Diseases