About this trial
The gold standard of twitch transdiaphragmatic pressure recordings would ultimately clear the fog around the rate of development of Ventilator induced Diaphragm Dysfunction (VIDD) in mechanically ventilated patients over time.
Through measurements made even after mechanical ventilation (MV) it could be clarified to what extent patients recover from VIDD.
Paired with cortical stimulation and electromyographic recordings of diaphragm muscle potentials, it could be explored to what extent decreased diaphragm excitability due to long term MV contributes to VIDD on the level of motor cortex.
Against that background the present project aims at determining the rate of decline in diaphragm function, strength and control in patients undergoing MV (including measurements after extubation).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Initiation of invasive mechanical ventilation in the Intensive Care Unit within 48 hours.
Expected duration of invasive mechanical ventilation of at least 5 days.
OR: elective bypass surgery with "planned" invasive mechanical ventilation
Disqualifiers
Body-mass-index (BMI) >40
Expected absence of active participation of the patient in study-related measurements after extubation
Alcohol or drug abuse
Non MRI compatible implant in the body
Trial population
Comprehensive assessment of diaphragm atrophy, function, strength and control in patients in whom invasive mechanical ventilation in the Intensive Care Unit had been initiated within 48 hours. Then, serial measurements every third day including 2 measurements after extubation.
Trial design
Case-control
Prospective
Treatments tested in this trial
Respiratory Muscle Testing
Diagnostic testComprehensive assessment of respiratory muscle function. Comprehensive assessment of respiratory muscle function to the point of its invasive assessment with recordings of twitch transdiaphragmatic pressure in response to magnetic phrenic nerve stimulation and stimulation of the lower thoracic nerve roots.
Treatment groups
Trial outcomes
Primary outcomes
Twitch transdiaphragmatic pressure in response to supramaximal magnetic stimulation of the phrenic nerve roots.
Cortical control of diaphragm function
Amplitude of the diaphragm motor evoked potentials (measured by surface electrodes attached to the diaphragm) following cortical magnetic stimulation of the phrenic nerve roots.
Secondary outcomes
Diaphragm ultrasound
Diaphragm thickening fraction on ultrasound
Systemic inflammation
Concentration of circulating Interleukin, high-sensitivity C-reactive protein (analyzed quantitatively based on a Levels venous blood sample).
Sponsors and contacts
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