Status:
COMPLETED
Mechanical Ventilation Controlled by the Electrical Activity of the Patient's Diaphragm - Effects on Cardiac Performance
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Conditions:
Respiratory Failure
Cardiac Failure
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- Male or female patients aged 18 - 85 years (extremes included)
- Mechanical ventilation (tracheally intubated or tracheotomized)
- 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
- 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
- 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
- Presence of a pulmonary artery catheter and an arterial pressure line
- Subject itself or its next of kin has given written informed consent
Exclusion
- Patient is less than 18 years or more than 80 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. The patient will not be enrolled in the study if the test result is positive.
- 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 (including 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 MV controlling for tidal volume or for airway pressure as per attending physician.
- Severe hemodynamic instability as judged by the 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00647361
Start Date
March 1 2008
End Date
June 1 2010
Last Update
July 19 2011
Active Locations (1)
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1
Department of Intensive Care Medicine, University Hospital
Bern, Canton of Bern, Switzerland, 3010