Muscle Force Assessment in the Intensive Care Unit and in Primary Myopathies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00735384
Recruitment Status : Recruiting
First Posted : August 14, 2008
Last Update Posted : January 16, 2018
University of Minnesota - Clinical and Translational Science Institute
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

August 13, 2008
August 14, 2008
January 16, 2018
September 2006
December 2018   (Final data collection date for primary outcome measure)
Skeletal Muscle Force in ICU Patients and Patients with Primary Myopathies [ Time Frame: ICU patients: 1-3 months; Myopathy patients: up to 5 years ]
Characterisation and follow up of the muscle force of the lower leg in severly ill patients of a intensive-care-unit. To characterise primary myopathy patients typical force pattern of the lower leg and to follow up their individual disease progression over many years
decreases and increases of skeletal muscle force values [ Time Frame: during critical ill state, and 1 to 2 months after ]
Complete list of historical versions of study NCT00735384 on Archive Site
Muscle forces pending on the Malignant Hyperthermia (MH) status of a patient (susceptible to MH or not susceptible to MH) [ Time Frame: at the time point of MH testing, i.e., at hospital admission ]
Muscle forces pending on the Malignant Hyperthermia (MH) status of a patient (susceptible to MH or not susceptible to MH) [ Time Frame: no time frame ]
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Muscle Force Assessment in the Intensive Care Unit and in Primary Myopathies
Application of Methodology of Non-invasive Stimulated Muscle Force Assessment to ICU Patients and Patients With Primary Myopathies to Characterize Their Muscle Weakness - Extension of the Study Protocol: 2008 to 2018

The primary aim of the project is to apply the non-invasive stimulated muscle force assessment system to i) intensive care unit patients and ii) patients with primary myopathy or subclinic myopathy (e.g., Duchenne muscular dystrophy, Myotonia, MH). The investigators will use this new methodology of force assessment to phenotype patients weakness during their illnesses (depict typical force pattern) and monitor recovery periods, or disease progression, respectively. This new system will be evaluated until the year 2018. The investigators will determine variables of isometric skeletal muscle force.

These systems should serve as force monitoring tools and help to guide therapies.

A force measuring system similar to one employed in previous studies will be redesigned with a new stimulator system and leg support system. This new, small, light and portable measurement system accurately measures patients' muscle forces. The system produces repeatable results. Over a long-time time period, this system will be applied to ICU patients and patients with primary myopathies, e.g. muscular dystrophy Duchenne or myotonias, and their ankle dorsiflexor isometric torques measured after electrical peroneal nerve stimulation. Torques will be amplified and converted into electrical signals by a Whetstone bridge, and data will be stored on a computer (LabView system). Stimulated torque responses will be obtained regularly, and subsequently the individualized curves will be determined. Electromyogram will be performed at each recording session. For all subjects possible, the investigators will continue to monitor their stimulated muscle forces during their recovery periods or disease progression. Type of data: Variables of isometric skeletal muscle contractions, such as peak torques, contraction and relaxation times and torque latencies. To find an assumed difference of 50% in strength, at least 30 individuals (power 0.9) are required.

Values will be compared to patients voluntary forces, determined by Muscle Research Council (MRC) and Manual Muscle Test (MMT) scores.

Additionally, skin resistances of edema patients will by determined employing a twitch stimulator and an oscilloscope. We are interested whether edema (fluid) changes tissue resistance. Data are required to redesign the new stimulation unit of the muscle force measuring system.

Observational Model: Case-Control
Time Perspective: Prospective
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Non-Probability Sample
Primary care clinic
  • Sepsis
  • Primary Myopathies
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  • Patients with critical illness myopathy
    Patients with,e.g., sepsis, with secondary myopathy
  • Patients with Primary Myopathies
    Patients with primary myopathy, e.g., Duchenne Muscular Dystrophy, Myotonia

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2018
December 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Any patient which fulfills the criteria for sepsis / septic shock according the definition of the American College of Chest Physicians/Society of Critical Care Medicine Consensus Conference
  • Patients who will be sedated, mechanically ventilated, and immobilized
  • Patients will be intubated the day of admission to ICU and started mechanically ventilated on a positive pressure ventilation modus
  • The severity of each patient¢s illness will be assessed using the Acute Physiology and Chronic Health Evaluation (APACHE) II score with required entry scores of a minimum of 15-20 Points
  • Patients suffering from a primary myopathy, e.g., Duchenne Muscular Dystrophy or subclinic myopathy, e.g. Malignant Hyperthermia.

Exclusion Criteria:

  • Patients with neuropathies, consuming diseases in an advanced state (metastatic cancer) and severe infectious diseases (e.g. AIDS, Hepatitis), as well as patients with injured legs and/or patients requiring neuromuscular blocking drugs.
  • Patients under the age of 18 yr.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact: Albert Urwyler, Professor MD +4161 265 2525
Contact: Hans F Ginz, MD +49 7621 41678600
P21/08//A05/08 ( Other Identifier: Else-Kröner-Fresenius-Stiftung 2008; SGAR / SSAR Fonds 2007, Schweizerische Muskelstiftung (SMS) 2016 )
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University Hospital, Basel, Switzerland
University Hospital, Basel, Switzerland
University of Minnesota - Clinical and Translational Science Institute
Study Director: Albert Urwyler, Professor MD Departments of Anaesthesia and Research, University of Basel Hospital, CH-4031, Switzerland
University Hospital, Basel, Switzerland
January 2018