diaphragm dysfunction respiratory muscle weakness
Conditions
Interventions
Subjects are treated with either levosimendan (continuous levosimendan infusion
of 0.2 µg/kg/min) or placebo for 6 hours. Before treatment and after treatment
patients perform a 30 minute weaning tr
Sponsors
Universitair Medisch Centrum Sint Radboud
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • age >18 year • mechanical ventilation for at least 3 days • PaO2/FiO2 ratio >200 mmHg • Ventilatory settings: Positive End Expiratory Pressure
Exclusion criteria
Exclusion criteria: • pre-existent muscle disease (congenital or acquired) or diseases / disorders know to be associated with myopathy including auto-immune diseases. • pre-existent cardiac disease (based on history, electrocardiography and transthoracic echocardiography) • upper airway / esophageal pathology (i.e. recent surgery, esophageal varices, diaphragmatic hernia) • phrenic nerve lesions • pregnancy, breast feeding • severe renal failure (serum creatinine > 450 µmol/L) • severe hepatic failure • recent (within 5 days) nasal bleeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure is the difference in neuro-mechanical efficiency of the diaphragm (i.e. the ratio of diaphragm electrical activity [Edi] and transdiaphragmatic pressure [Pdi]) before and after levosimendan administration during a CPAP trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Neuro-ventilatory efficiency of the diaphragm (i.e. the ratio of diaphragm electrical activity [Edi] and tidal volume [Vt]). • Oxygen consumption (VO2). • Carbon dioxide production (VCO2). • Oxygen level in blood (PaO2). • Carbon dioxide level in blood (PaCO2). • Accessory muscle recruitment (also in response to various pressure support level) i. electrical activity of the sternocleidomastoid muscle ii. electrical activity of the scalene muscles iii. electrical activity of the intercostal muscles iv. electrical activity of the genioglossal muscles | — |
Countries
Netherlands
Outcome results
None listed