Short Term Effects of Neurally Adjusted Ventilatory Assist and Pressure Support Ventilation on Cardiac Performance

Insel Gruppe AG, University Hospital Bern1 site in 1 country15 target enrollmentMarch 2008

ConditionsRespiratory Failure Cardiac Failure

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Respiratory Failure
Sponsor: Insel Gruppe AG, University Hospital Bern
Enrollment: 15
Locations: 1
Primary Endpoint: Cardiac stroke volume index.
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2008

End Date

June 2010

Last Updated

14 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Insel Gruppe AG, University Hospital Bern

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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