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
  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 NAVA on cardiac performance in critically ill, mechanically ventilated patients.


Condition Intervention 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
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Short Term Effects of Neurally Adjusted Ventilatory Assist and Pressure Support Ventilation on Cardiac Performance

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Cardiac stroke volume index. [ Time Frame: end of experimental periods ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Global delivery of oxygen [ Time Frame: end of experimental period ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: March 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

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

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00647361

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

Publications:
Responsible Party: Lukas Brander, MD, University Hospital - Inselspital
ClinicalTrials.gov Identifier: NCT00647361     History of Changes
Other Study ID Numbers: KEK BE 217-06
Study First Received: March 19, 2008
Last Updated: July 18, 2011
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital Inselspital, Berne:
respiratory insufficiency
respiration
ventilators
diaphragm
electromyography
mechanical ventilation

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

ClinicalTrials.gov processed this record on August 28, 2014