How diaphragm strength changes during and after mechanical ventilation
Development of Diaphragm Atrophy, Dysfunction and Inhibited Cortical Control in Mechanical Ventilation
This project will try to see how quickly the diaphragm weakens in ICU patients on mechanical ventilation and whether it recovers after they are taken off the ventilator.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | RWTH Aachen University Academic / other |
| Locations | 1 site (Aachen) |
| Trial ID | NCT05211661 on ClinicalTrials.gov |
What this trial studies
This is an observational program that will follow ICU patients who start invasive mechanical ventilation to measure diaphragm function over time. Investigators will use twitch transdiaphragmatic pressure recordings as the primary physiological measure, combined with cortical stimulation and diaphragm electromyography to probe neural contributions. Measurements will be repeated during mechanical ventilation and after extubation to track decline and potential recovery. Participants are enrolled early in ventilation (within 48 hours) and are expected to remain ventilated for at least five days.
Who should consider this trial
Good fit: Adults in the ICU who started invasive mechanical ventilation within the past 48 hours and are expected to remain ventilated for at least five days.
Not a fit: Patients likely to need only brief ventilation (<5 days), or those with BMI >40, active substance abuse, epilepsy, non‑MRI‑compatible implants, or who cannot actively participate after extubation are unlikely to benefit from joining.
Why it matters
Potential benefit: If successful, the findings could help clinicians time weaning and design ventilation strategies to reduce diaphragm weakness and improve recovery.
How similar studies have performed: Animal and some human studies have demonstrated rapid ventilator‑induced diaphragm weakness, but few longitudinal studies have combined twitch transdiaphragmatic pressure with cortical stimulation and EMG.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Initiation of invasive mechanical ventilation in the Intensive Care Unit within 48 hours. * Expected duration of invasive mechanical ventilation of at least 5 days. Exclusion Criteria: * 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 * Slipped disc * Epilepsy * Patients in an interdependence or with an employment contract with the principal investigator, Co-PI or his deputy.
Where this trial is running
Aachen
- RWTH Aachen University — Aachen, Germany (Recruiting)
Study contacts
- Principal investigator: Jens Spiesshoefer, MD — RWTH Aachen University Hospital
- Study coordinator: Michael Dreher, Professor
- Email: mdreher@ukaachen.de
- Phone: +4924180
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.