Actively Recruiting

Age: 18Years - 75Years
All Genders
ID05211661

Development of Diaphragm Atrophy, Dysfunction and Inhibited Cortical Control in Mechanical Ventilation

Led by RWTH Aachen University · Updated on 2026-02-09

15

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the development and recovery of ventilator induced diaphragm dysfunction (VIDD) in patients who require mechanical ventilation (MV) in the intensive care unit. This observational study aims to understand how diaphragm function, strength, and control decline over time during MV, including after removal of the breathing tube. The study also explores whether decreased diaphragm responsiveness from long-term MV affects the brain's motor control of the diaphragm. Participants undergo detailed respiratory muscle testing, including measurements of twitch transdiaphragmatic pressure triggered by magnetic stimulation of the phrenic nerves, and assessments of cortical control of diaphragm function. These tests are performed first within 48 hours of starting MV, then every three days, including two sessions after extubation. Additional evaluations include diaphragm ultrasound and monitoring of systemic inflammation. During the study, patients will have repeated assessments to track changes in diaphragm function and brain control over two years. Researchers will measure twitch pressures, diaphragm muscle activity, and inflammation markers. This helps clarify the rate of diaphragm decline and potential recovery after MV. The study is sponsored by RWTH Aachen University and involves close monitoring of patients in critical care settings.

CONDITIONS

Brief Title

Diaphragm Atrophy and Dysfunction in Mechanical Ventilation

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Initiation of invasive mechanical ventilation in the Intensive Care Unit within 48 hours
  • Expected duration of invasive mechanical ventilation of at least 5 days
  • Age between 18 and 75 years
Not Eligible

You will not qualify if you...

  • Body-mass-index (BMI) greater than 40
  • Expected inability to actively participate in study measurements after extubation
  • History of alcohol or drug abuse
  • Presence of non-MRI compatible implants in the body
  • History of slipped disc
  • History of epilepsy
  • Patients with employment or interdependence relationship with the principal investigator, Co-PI, or their deputy

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - Up to 48 hours before mechanical ventilation initiation

Participants are screened for eligibility to participate in the trial.

Monitoring

Duration - Throughout mechanical ventilation and up to 2 years after extubation

Participants undergo serial comprehensive assessments of respiratory muscle function, including invasive measurements like twitch transdiaphragmatic pressure in response to magnetic phrenic nerve stimulation.

Measurements every 3 days during mechanical ventilation, including 2 measurements after extubation

Trial Site Locations

Total: 1 location

1

RWTH Aachen University

Aachen, Germany, 52074

Actively Recruiting

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Research Team

M

Michael Dreher, Professor

J

Jens Spiesshoefer, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Evaluation of Respiratory Muscle Strength and Diaphragm Ultrasound: Normative Values, Theoretical Considerations, and Practical Recommendations.

Jens Spiesshoefer, Simon Herkenrath, Carolin Henke...

https://pubmed.ncbi.nlm.nih.gov/32396905

Assessment of Central Drive to the Diaphragm by Twitch Interpolation: Normal Values, Theoretical Considerations, and Future Directions.

Jens Spiesshoefer, Carolin Henke, Simon Herkenrath...

https://pubmed.ncbi.nlm.nih.gov/31352459

German National Guideline for Treating Chronic Respiratory Failure with Invasive and Non-Invasive Ventilation: Revised Edition 2017 - Part 1.

Wolfram Windisch, Jens Geiseler, Karsten Simon...

https://pubmed.ncbi.nlm.nih.gov/29945148

German National Guideline for Treating Chronic Respiratory Failure with Invasive and Non-Invasive Ventilation - Revised Edition 2017: Part 2.

Wolfram Windisch, Jens Geiseler, Karsten Simon...

https://pubmed.ncbi.nlm.nih.gov/29945156