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

This study has been completed.
Sponsor:
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT00647361
First received: March 19, 2008
Last updated: July 18, 2011
Last verified: July 2011

March 19, 2008
July 18, 2011
March 2008
June 2010   (final data collection date for primary outcome measure)
Cardiac stroke volume index. [ Time Frame: end of experimental periods ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00647361 on ClinicalTrials.gov Archive Site
Global delivery of oxygen [ Time Frame: end of experimental period ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Mechanical Ventilation Controlled by the Electrical Activity of the Patient's Diaphragm - Effects on Cardiac Performance
Short Term Effects of Neurally Adjusted Ventilatory Assist and Pressure Support Ventilation on Cardiac Performance

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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Respiratory Failure
  • Cardiac Failure
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)
Experimental: NAVA
Intervention: Device: Neurally adjusted ventilatory assist (NAVA) provided by a commercially available mechanical ventilator (Servo i, Maquet Critical Care, Solna, Sweden).
Sinderby C, Navalesi P, Beck J, Skrobik Y, Comtois N, Friberg S, Gottfried SB, Lindstrom L. Neural control of mechanical ventilation in respiratory failure. Nat Med. 1999 Dec;5(12):1433-6. Review. No abstract available.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
June 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00647361
KEK BE 217-06
No
Lukas Brander, MD, University Hospital - Inselspital
University Hospital Inselspital, Berne
Not Provided
Principal Investigator: Lukas Brander, MD Department of Intensive Care Medicine, University Hospital - Inselspital, Bern, Switzerland
University Hospital Inselspital, Berne
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP