Diaphragm Atrophy and Dysfunction in Mechanical Ventilation
NCT ID: NCT05211661
Last Updated: 2026-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
15 participants
OBSERVATIONAL
2022-10-10
2028-06-01
Brief Summary
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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).
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Detailed Description
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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).
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Expected duration of invasive mechanical ventilation of at least 5 days.
Exclusion Criteria
* 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
* Slipped disc
* Epilepsy
* Patients in an interdependence or with an employment contract with the principal investigator, Co-PI or his deputy.
18 Years
75 Years
ALL
No
Sponsors
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RWTH Aachen University
OTHER
Responsible Party
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Univ.-Prof. Dr. med. Michael Dreher
Professor Michael Dreher
Principal Investigators
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Michael Dreher, Professor
Role: STUDY_CHAIR
RWTH Aachen University Hospital
Jens Spiesshoefer, MD
Role: PRINCIPAL_INVESTIGATOR
RWTH Aachen University Hospital
Locations
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RWTH Aachen University
Aachen, , Germany
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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, 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.
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. doi: 10.1152/japplphysiol.01099.2003. Epub 2004 Mar 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 1. Respiration. 2018;96(1):66-97. doi: 10.1159/000488001. 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 2. Respiration. 2018;96(2):171-203. doi: 10.1159/000488667. Epub 2018 Jun 26.
Other Identifiers
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CTCA 21-279
Identifier Type: -
Identifier Source: org_study_id
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