Diaphragm Atrophy and Dysfunction in Mechanical Ventilation (DAM)

October 25, 2022 updated by: Univ.-Prof. Dr. med. Michael Dreher, RWTH Aachen University

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.

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Aachen, Germany, 52074
        • Recruiting
        • RWTH Aachen University
        • Contact:
        • Principal Investigator:
          • Jens Spiesshoefer, MD
        • Sub-Investigator:
          • Binaya Regmi, MD
        • Sub-Investigator:
          • Jonathan Enriquez-Geppert
        • Sub-Investigator:
          • Mehdi Senol

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Invasively ventilated patients (n=15)

First measurement (comprehensive protocol) within 48 hours from initiation of MV.

Serial measurements every third day including 2 measurements after extubation.
Diagnostic test: Respiratory 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Twitch transdiaphragmatic pressure in response to supramaximal magnetic stimulation of the phrenic nerve roots.
Time Frame: 2 years
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 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diaphragm ultrasound
Time Frame: 2 years
Diaphragm thickening fraction on ultrasound
2 years
Systemic inflammation
Time Frame: 2 years
Concentration of circulating Interleukin, high-sensitivity C-reactive protein (analyzed quantitatively based on a Levels venous blood sample).
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RWTH Aachen University

Investigators

  • Study Chair: Michael Dreher, Professor, RWTH Aachen University Hospital
  • Principal Investigator: Jens Spiesshoefer, MD, RWTH Aachen University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2022

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

January 4, 2022

First Submitted That Met QC Criteria

January 14, 2022

First Posted (Actual)

January 27, 2022

Study Record Updates

Last Update Posted (Actual)

October 26, 2022

Last Update Submitted That Met QC Criteria

October 25, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTCA 21-279

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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