Diaphragm IssuesDAMNCT05211661
Diaphragm Atrophy and Dysfunction in Mechanical Ventilation
An observational study of Diaphragm Issues and Mechanical Ventilation Complication, run by RWTH Aachen University at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diaphragm Issues, Mechanical Ventilation Complication, Respiratory Failure
- What is being tested?
- Respiratory Muscle Testing
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 10 Oct 2022to 1 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Comprehensive assessment of diaphragm atrophy, function, strength and control in patients in whom invasive mechanical ventilation in the Intensive Care Unit had been initiated within 48 hours. Then, serial measurements every third day including 2 measurements after extubation.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
RWTH Aachen University
Aachen, 52074
Michael Dreher, Professor, +4924180 ext. 88763, mdreher@ukaachen.de
Jens Spiesshoefer, MD
About this study
Official title: Development of Diaphragm Atrophy, Dysfunction and Inhibited Cortical Control 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.
Read more
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).
Read the 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).
- Conditions
- Diaphragm Issues, Mechanical Ventilation Complication, Respiratory Failure, Intensive Care (ICU) Myopathy
- Being tested
- Respiratory Muscle Testing
- Medical subject headings
- Respiratory Insufficiency, Muscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory Muscle TestingDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Invasively ventilated patients (n=20) | First measurement (comprehensive protocol) within 48 hours from initiation of MV.
Serial measurements every third day including 2 measurements after extubation. Receives: Diagnostic Test: Respiratory Muscle Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Twitch transdiaphragmatic pressure in response to supramaximal magnetic stimulation of the phrenic nerve roots.
Measured: 2 years
Cortical control of diaphragm function
Amplitude of the diaphragm motor evoked potentials (measured by surface electrodes attached to the diaphragm) following cortical magnetic stimulation of the phrenic nerve roots.
Measured: 2 years
Secondary outcomes (2)
Diaphragm ultrasound
Diaphragm thickening fraction on ultrasound
Measured: 2 years
Systemic inflammation
Concentration of circulating Interleukin, high-sensitivity C-reactive protein (analyzed quantitatively based on a Levels venous blood sample).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start10 Oct 2022
- Primary completion1 May 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Diaphragm IssuesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Univ.-Prof. Dr. med. Michael Dreher, RWTH Aachen University
- Investigators
- Michael Dreher, Professor, Study chair, Department of Pneumology and Intensive Care Medicine, Faculty of Medicine, RWTH Aachen University, Pauwelsstraße 30, 52074, Aachen, Germany.Jens Spiesshoefer, MD, Principal investigator, Department of Pneumology and Intensive Care Medicine, Faculty of Medicine, RWTH Aachen University, Pauwelsstraße 30, 52074, Aachen, Germany.Thomas Breuer, Professor, Study director, Department of Intensive Care Medicine, Faculty of Medicine, RWTH Aachen University, Pauwelsstraße 30, 52074, Aachen, Germany.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05211661
- Sponsor's protocol ID
- CTCA 21-279
- Acronym
- DAM
- Status last verified
- Sep 2026
- First submitted
- 4 Jan 2022
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Spiesshoefer J, Herkenrath S, Henke C, Langenbruch L, Schneppe M, Randerath W, Young P, Brix T, Boentert M. Evaluation of Respiratory Muscle Strength and Diaphragm Ultrasound: Normative Values, Theoretical Considerations, and Practical Recommendations. Respiration. 2020;99(5):369-381. doi: 10.1159/000506016. Epub 2020 May 12.
PubMed 32396905Spiesshoefer J, Henke C, Herkenrath S, Randerath W, Brix T, Young P, Boentert M. Assessment of Central Drive to the Diaphragm by Twitch Interpolation: Normal Values, Theoretical Considerations, and Future Directions. Respiration. 2019;98(4):283-293. doi: 10.1159/000500726. Epub 2019 Jul 26.
PubMed 31352459Spiesshoefer J, Henke C, Herkenrath S, Brix T, Randerath W, Young P, Boentert M. Transdiapragmatic pressure and contractile properties of the diaphragm following magnetic stimulation. Respir Physiol Neurobiol. 2019 Aug;266:47-53. doi: 10.1016/j.resp.2019.04.011. Epub 2019 Apr 25.
PubMed 31029769Sharshar T, Ross ET, Hopkinson NS, Porcher R, Nickol AH, Jonville S, Dayer MJ, Hart N, Moxham J, Lofaso F, Polkey MI. Depression of diaphragm motor cortex excitability during mechanical ventilation. J Appl Physiol (1985). 2004 Jul;97(1):3-10. doi: 10.1152/japplphysiol.01099.2003. Epub 2004 Mar 12.
PubMed 15020575Windisch W, Geiseler J, Simon K, Walterspacher S, Dreher M; on behalf of the Guideline Commission. German National Guideline for Treating Chronic Respiratory Failure with Invasive and Non-Invasive Ventilation: Revised Edition 2017 - Part 1. Respiration. 2018;96(1):66-97. doi: 10.1159/000488001. Epub 2018 Jun 26.
PubMed 29945148Windisch W, Geiseler J, Simon K, Walterspacher S, Dreher M; on behalf of the Guideline Commission. German National Guideline for Treating Chronic Respiratory Failure with Invasive and Non-Invasive Ventilation - Revised Edition 2017: Part 2. Respiration. 2018;96(2):171-203. doi: 10.1159/000488667. Epub 2018 Jun 26.
PubMed 29945156
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Diaphragm Atrophy, Dysfunction and Inhibited Cortical Control in Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT05211661
- Acronym / sponsor ID
- DAM / CTCA 21-279
- Conditions
- Diaphragm Issues, Mechanical Ventilation Complication, Respiratory Failure, Intensive Care (ICU) Myopathy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 27 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Invasively ventilated patients (n=20) | – | Diagnostic Test: Respiratory Muscle TestingFirst measurement (comprehensive protocol) within 48 hours from initiation of MV. Serial measurements every third day including 2 measurements after extubation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Comprehensive assessment of diaphragm atrophy, function, strength and control in patients in whom invasive mechanical ventilation in the Intensive Care Unit had been initiated within 48 hours. Then, serial measurements every third day including 2 measurements after extubation.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Respiratory Muscle TestingComprehensive 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. | Diagnostic test | Invasively ventilated patients (n=20) |
Primary outcome
Twitch transdiaphragmatic pressure in response to supramaximal magnetic stimulation of the phrenic nerve roots.
Time frame: 2 years
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.
2 secondary outcomes
Diaphragm ultrasound
Time frame: 2 years
Systemic inflammation
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Background: PubMed 32396905Spiesshoefer J, Herkenrath S, Henke C, Langenbruch L, Schneppe M, Randerath W, Young P, Brix T, Boentert M. Evaluation of Respiratory Muscle Strength and Diaphragm Ultrasound: Normative Values, Theoretical Considerations, and Practical Recommendations. Respiration. 2020;99(5):369-381. doi: 10.1159/000506016. Epub 2020 May 12.
- Background: PubMed 31352459Spiesshoefer J, Henke C, Herkenrath S, Randerath W, Brix T, Young P, Boentert M. Assessment of Central Drive to the Diaphragm by Twitch Interpolation: Normal Values, Theoretical Considerations, and Future Directions. Respiration. 2019;98(4):283-293. doi: 10.1159/000500726. Epub 2019 Jul 26.
- Background: PubMed 31029769Spiesshoefer J, Henke C, Herkenrath S, Brix T, Randerath W, Young P, Boentert M. Transdiapragmatic pressure and contractile properties of the diaphragm following magnetic stimulation. Respir Physiol Neurobiol. 2019 Aug;266:47-53. doi: 10.1016/j.resp.2019.04.011. Epub 2019 Apr 25.
- Background: PubMed 15020575Sharshar T, Ross ET, Hopkinson NS, Porcher R, Nickol AH, Jonville S, Dayer MJ, Hart N, Moxham J, Lofaso F, Polkey MI. Depression of diaphragm motor cortex excitability during mechanical ventilation. J Appl Physiol (1985). 2004 Jul;97(1):3-10. doi: 10.1152/japplphysiol.01099.2003. Epub 2004 Mar 12.
- Background: PubMed 29945148Windisch W, Geiseler J, Simon K, Walterspacher S, Dreher M; on behalf of the Guideline Commission. German National Guideline for Treating Chronic Respiratory Failure with Invasive and Non-Invasive Ventilation: Revised Edition 2017 - Part 1. Respiration. 2018;96(1):66-97. doi: 10.1159/000488001. Epub 2018 Jun 26.
- Background: PubMed 29945156Windisch W, Geiseler J, Simon K, Walterspacher S, Dreher M; on behalf of the Guideline Commission. German National Guideline for Treating Chronic Respiratory Failure with Invasive and Non-Invasive Ventilation - Revised Edition 2017: Part 2. Respiration. 2018;96(2):171-203. doi: 10.1159/000488667. Epub 2018 Jun 26.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Dreher, Professor study chair
Department of Pneumology and Intensive Care Medicine, Faculty of Medicine, RWTH Aachen University, Pauwelsstraße 30, 52074, Aachen, Germany.
Jens Spiesshoefer, MD principal investigator
Department of Pneumology and Intensive Care Medicine, Faculty of Medicine, RWTH Aachen University, Pauwelsstraße 30, 52074, Aachen, Germany.
Thomas Breuer, Professor study director
Department of Intensive Care Medicine, Faculty of Medicine, RWTH Aachen University, Pauwelsstraße 30, 52074, Aachen, Germany.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diaphragm Issues and Mechanical Ventilation Complication, run by RWTH Aachen University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Dreher, Professor (+4924180 ext. 88763, mdreher@ukaachen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Twitch transdiaphragmatic pressure in response to supramaximal magnetic stimulation of the phrenic nerve roots. (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05211661, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.