NCT05211661

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
25mo left

Started Oct 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress63%
Oct 2022Jun 2028

First Submitted

Initial submission to the registry

January 4, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 27, 2022

Completed
9 months until next milestone

Study Start

First participant enrolled

October 10, 2022

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

5.6 years

First QC Date

January 4, 2022

Last Update Submit

February 4, 2026

Conditions

Respiratory FailureIntensive Care (ICU) MyopathyDiaphragm IssuesMechanical Ventilation Complication

Outcome Measures

Primary Outcomes (2)

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

    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.

    2 years

Secondary Outcomes (2)

  • Diaphragm ultrasound

    2 years

  • Systemic inflammation

    2 years

Study Arms (1)

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

Interventions

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.

Invasively ventilated patients (n=15)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Initiation of invasive mechanical ventilation in the Intensive Care Unit within 48 hours.
  • Expected duration of invasive mechanical ventilation of at least 5 days.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RWTH Aachen University

Aachen, 52074, Germany

RECRUITING

Related Publications (6)

  • 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.

    PMID: 32396905BACKGROUND

  • Spiesshoefer 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.

    PMID: 31352459BACKGROUND

  • Spiesshoefer 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.

    PMID: 31029769BACKGROUND

  • Sharshar 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.

    PMID: 15020575BACKGROUND

  • Windisch 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.

    PMID: 29945148BACKGROUND

  • Windisch 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.

    PMID: 29945156BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples obtained based on venous puncture

MeSH Terms

Conditions

Respiratory InsufficiencyMuscular Diseases

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Michael Dreher, Professor

    RWTH Aachen University Hospital

    STUDY CHAIR

  • Jens Spiesshoefer, MD

    RWTH Aachen University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Dreher, Professor

CONTACT

+4924180mdreher@ukaachen.de

Jens Spiesshoefer, MD

CONTACT

+4924180jspiesshoefe@ukaachen.de

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Michael Dreher

Study Record Dates

First Submitted

January 4, 2022

First Posted

January 27, 2022

Study Start

October 10, 2022

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

June 1, 2028

Last Updated

February 9, 2026

Record last verified: 2026-02

Locations

DE(1)