Diaphragm Atrophy and Dysfunction in Mechanical Ventilation

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorRWTH Aachen University

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Respiratory Muscle Testing

    Diagnostic test

    Comprehensive 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

20 Participants
are divided into 1 treatment group
Group A: Invasively ventilated patients (n=20)1 intervention

Trial outcomes

Primary outcomes

1

Twitch transdiaphragmatic pressure in response to supramaximal magnetic stimulation of the phrenic nerve roots.

Time frame
2 years
2

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.

Time frame
2 years

Secondary outcomes

1

Diaphragm ultrasound

Diaphragm thickening fraction on ultrasound

Time frame
2 years
2

Systemic inflammation

Concentration of circulating Interleukin, high-sensitivity C-reactive protein (analyzed quantitatively based on a Levels venous blood sample).

Time frame
2 years

Other outcomes

Sponsors and contacts

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