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Идёт набор NCT05211661

Diaphragm Atrophy and Dysfunction in Mechanical Ventilation

— Наблюдательное Diaphragm Issues Mechanical Ventilation Complication Respiratory Failure Intensive Care (ICU) Myopathy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Respiratory Muscle Testing.
Кому может быть актуально
Состояния в реестре: Diaphragm Issues, Mechanical Ventilation Complication, Respiratory Failure, Intensive Care (ICU) Myopathy. Базовые параметры: 18 лет — 75 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Германия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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).

Подробное описание

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).

Вмешательства

  • Диагностический тест 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.

Первичные конечные точки

  • Twitch transdiaphragmatic pressure in response to supramaximal magnetic stimulation of the phrenic nerve roots. [Срок оценки: 2 years]
  • Cortical control of diaphragm function [Срок оценки: 2 years]
Вторичные конечные точки (2)
  • Diaphragm ultrasound [Срок оценки: 2 years]
  • Systemic inflammation [Срок оценки: 2 years]

Критерии участия

Критерии включения

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

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Германия · 1 центр
  • RWTH Aachen University — Aachen

Публикации

  • 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 32396905
  • 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 31352459
  • 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 31029769
  • 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 15020575
  • 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 29945148
  • 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 29945156

Идентификаторы

NCT: NCT05211661 · CTCA 21-279

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗