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Diaphragm Atrophy and Dysfunction in Mechanical Ventilation

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05211661
Acronym
DAM
Enrollment
20
Registered
2022-01-27
Start date
2022-10-10
Completion date
2028-06-01
Last updated
2026-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diaphragm Issues, Intensive Care (ICU) Myopathy, Mechanical Ventilation Complication, Respiratory Failure

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).

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).

Interventions

DIAGNOSTIC_TESTRespiratory 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.

Sponsors

RWTH Aachen University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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. * OR: elective bypass surgery with "planned" invasive mechanical ventilation

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.

Design outcomes

Primary

MeasureTime frameDescription
Twitch transdiaphragmatic pressure in response to supramaximal magnetic stimulation of the phrenic nerve roots.2 years
Cortical control of diaphragm function2 yearsAmplitude of the diaphragm motor evoked potentials (measured by surface electrodes attached to the diaphragm) following cortical magnetic stimulation of the phrenic nerve roots.

Secondary

MeasureTime frameDescription
Diaphragm ultrasound2 yearsDiaphragm thickening fraction on ultrasound
Systemic inflammation2 yearsConcentration of circulating Interleukin, high-sensitivity C-reactive protein (analyzed quantitatively based on a Levels venous blood sample).

Countries

Germany

Contacts

CONTACTMichael Dreher, Professor
mdreher@ukaachen.de+4924180
CONTACTJens Spiesshoefer, MD
jspiesshoefe@ukaachen.de+4924180
STUDY_CHAIRMichael Dreher, Professor

Department of Pneumology and Intensive Care Medicine, Faculty of Medicine, RWTH Aachen University, Pauwelsstraße 30, 52074, Aachen, Germany.

PRINCIPAL_INVESTIGATORJens Spiesshoefer, MD

Department of Pneumology and Intensive Care Medicine, Faculty of Medicine, RWTH Aachen University, Pauwelsstraße 30, 52074, Aachen, Germany.

STUDY_DIRECTORThomas Breuer, Professor

Department of Intensive Care Medicine, Faculty of Medicine, RWTH Aachen University, Pauwelsstraße 30, 52074, Aachen, Germany.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 16, 2026