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NCT Number: NCT05211661

Diaphragm Atrophy and Dysfunction in Mechanical Ventilation

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).

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

RWTH Aachen University

Aachen, 52074, Germany

Location status: Recruiting

Location contact

Binaya Regmi, MD

SUB_INVESTIGATOR

Jens Spiesshoefer, MD

PRINCIPAL_INVESTIGATOR

Jonathan Enriquez-Geppert

SUB_INVESTIGATOR

Mehdi Senol

SUB_INVESTIGATOR

Michael Dreher, Professor

CONTACT

[email protected]

+4924180 ext. 88763

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Respiratory Muscle Testing

Diagnostic Test

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.

Primary outcomes

  1. Twitch transdiaphragmatic pressure in response to supramaximal magnetic stimulation of the phrenic nerve roots.

    Time frame: 2 years

  2. Cortical control of diaphragm function

    Time frame: 2 years

    Amplitude of the diaphragm motor evoked potentials (measured by surface electrodes attached to the diaphragm) following cortical magnetic stimulation of the phrenic nerve roots.

Secondary outcomes

  1. Diaphragm ultrasound

    Time frame: 2 years

    Diaphragm thickening fraction on ultrasound

  2. Systemic inflammation

    Time frame: 2 years

    Concentration of circulating Interleukin, high-sensitivity C-reactive protein (analyzed quantitatively based on a Levels venous blood sample).

Study contacts

Contact information is provided by the study sponsor or research team.

Jens Spiesshoefer, MD

CONTACT

[email protected]

+4924180 ext. 37036

Michael Dreher, Professor

CONTACT

[email protected]

+4924180 ext. 88763

Sponsors and collaborators

Lead sponsor

RWTH Aachen University

Other

Registry information

Official study title

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

Acronym: DAM

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Jan 27, 2022
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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