Diaphragm Atrophy and Dysfunction in Mechanical Ventilation

Recruiting

• Conditions: Diaphragm Issues; Respiratory Failure; Intensive Care (ICU) Myopathy; Mechanical Ventilation Complication
• Interventions: Diagnostic Test: Respiratory Muscle Testing

• Registration Number: NCT05211661
• Lead Sponsor: RWTH Aachen University

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).

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 Timeline

• Study First Submitted: 2022-01-04
• Study First Submitted QC: 2022-01-14
• Study First Posted: 2022-01-27
• Status Verified: 2022-10
• Study Start: 2022-10-10
• Last Update Submitted: 2022-10-25
• Last Update Posted: 2022-10-26
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Invasively ventilated patients (n=15)	Respiratory Muscle Testing	First measurement (comprehensive protocol) within 48 hours from initiation of MV. Serial measurements every third day including 2 measurements after extubation.

Primary Outcome Measures

Name	Time	Method
Twitch transdiaphragmatic pressure in response to supramaximal magnetic stimulation of the phrenic nerve roots.	2 years
Cortical control of diaphragm function	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 Outcome Measures

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

Trial Locations

Locations (1)

RWTH Aachen University; 🇩🇪 Aachen, Germany