DAM: Diaphragm Atrophy and Dysfunction in Mechanical Ventilation
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
Evidence both from animal and human studies support the development of ventilator induced diaphragm dysfunction (VIDD) from as early as 24 hours of mechanical ventilation (MV) in the intensive care unit (ICU).
However, while the concept of VIDD seems to be proven now, several questions remain unanswered regarding its actual rate of development and (potentially) recovery after MV.
The gold standard of twitch transdiaphragmatic pressure recordings would ultimately clear the fog around the rate of development of VIDD over time.
Through measurements made even after 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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Invasively ventilated patients (n=15) First measurement (comprehensive protocol) within 48 hours from initiation of MV. Serial measurements every third day including 2 measurements after extubation. |
Diagnostic Test: Respiratory Muscle Testing
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.
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Outcome Measures
Primary Outcome Measures
- Twitch transdiaphragmatic pressure in response to supramaximal magnetic stimulation of the phrenic nerve roots. [2 years]
- Cortical control of diaphragm function [2 years]
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 Outcome Measures
- Diaphragm ultrasound [2 years]
Diaphragm thickening fraction on ultrasound
- Systemic inflammation [2 years]
Concentration of circulating Interleukin, high-sensitivity C-reactive protein (analyzed quantitatively based on a Levels venous blood sample).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Initiation of invasive mechanical ventilation in the Intensive Care Unit within 48 hours.
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Expected duration of invasive mechanical ventilation of at least 5 days.
Exclusion Criteria:
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Body-mass-index (BMI) >40
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Expected absence of active participation of the patient in study-related measurements after extubation
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Alcohol or drug abuse
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Non MRI compatible implant in the body
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Slipped disc
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Epilepsy
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Patients in an interdependence or with an employment contract with the principal investigator, Co-PI or his deputy.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | RWTH Aachen University | Aachen | Germany | 52074 |
Sponsors and Collaborators
- RWTH Aachen University
Investigators
- Study Chair: Michael Dreher, Professor, RWTH Aachen University Hospital
- Principal Investigator: Jens Spiesshoefer, MD, RWTH Aachen University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- Sharshar T, Ross ET, Hopkinson NS, Porcher R, Nickol AH, Jonville S, Dayer MJ, Hart N, Moxham J, Lofaso F, Polkey MI. Depression of diaphragm motor cortex excitability during mechanical ventilation. J Appl Physiol (1985). 2004 Jul;97(1):3-10. Epub 2004 Mar 12.
- Spiesshoefer J, Henke C, Herkenrath S, Brix T, Randerath W, Young P, Boentert M. Transdiapragmatic pressure and contractile properties of the diaphragm following magnetic stimulation. Respir Physiol Neurobiol. 2019 Aug;266:47-53. doi: 10.1016/j.resp.2019.04.011. Epub 2019 Apr 25.
- Spiesshoefer J, Henke C, Herkenrath S, Randerath W, Brix T, Young P, Boentert M. Assessment of Central Drive to the Diaphragm by Twitch Interpolation: Normal Values, Theoretical Considerations, and Future Directions. Respiration. 2019;98(4):283-293. doi: 10.1159/000500726. Epub 2019 Jul 26.
- Spiesshoefer J, Herkenrath S, Henke C, Langenbruch L, Schneppe M, Randerath W, Young P, Brix T, Boentert M. Evaluation of Respiratory Muscle Strength and Diaphragm Ultrasound: Normative Values, Theoretical Considerations, and Practical Recommendations. Respiration. 2020;99(5):369-381. doi: 10.1159/000506016. Epub 2020 May 12.
- Windisch W, Geiseler J, Simon K, Walterspacher S, Dreher M; on behalf of the Guideline Commission. German National Guideline for Treating Chronic Respiratory Failure with Invasive and Non-Invasive Ventilation - Revised Edition 2017: Part 2. Respiration. 2018;96(2):171-203. doi: 10.1159/000488667. Epub 2018 Jun 26.
- Windisch W, Geiseler J, Simon K, Walterspacher S, Dreher M; on behalf of the Guideline Commission. German National Guideline for Treating Chronic Respiratory Failure with Invasive and Non-Invasive Ventilation: Revised Edition 2017 - Part 1. Respiration. 2018;96(1):66-97. doi: 10.1159/000488001. Epub 2018 Jun 26.
- CTCA 21-279