Diaphragm Atrophy and Dysfunction in Mechanical Ventilation (DAM)

RWTH Aachen University

Status: Enrolling

Conditions: Diaphragm Issues; Respiratory Failure; Mechanical Ventilation Complication; Intensive Care (ICU) Myopathy

Treatments: Diagnostic Test: Respiratory Muscle Testing

Study type: Observational

Funder types: Other

Identifiers

NCT05211661

CTCA 21-279

Details and patient eligibility

About

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).

Full 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).

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

15 participants in 1 patient group

Invasively ventilated patients (n=15)

Description:

First measurement (comprehensive protocol) within 48 hours from initiation of MV. Serial measurements every third day including 2 measurements after extubation.

Treatment:

Diagnostic Test: Respiratory Muscle Testing