Muscle Force Assessment in the Intensive Care Unit and in Primary Myopathies
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| ClinicalTrials.gov Identifier: NCT00735384 |
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Recruitment Status :
Recruiting
First Posted : August 14, 2008
Last Update Posted : January 16, 2018
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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.
| Condition or disease |
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| Sepsis Primary Myopathies |
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.
| Study Type : | Observational |
| Estimated Enrollment : | 80 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Prospective |
| Official Title: | 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 |
| Study Start Date : | September 2006 |
| Estimated Primary Completion Date : | December 2018 |
| Estimated Study Completion Date : | December 2018 |
| Group/Cohort |
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Patients with critical illness myopathy
Patients with,e.g., sepsis, with secondary myopathy
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Patients with Primary Myopathies
Patients with primary myopathy, e.g., Duchenne Muscular Dystrophy, Myotonia
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- 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
- 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 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00735384
| Contact: Albert Urwyler, Professor MD | +4161 265 2525 | Albert.Urwyler@usb.ch | |
| Contact: Hans F Ginz, MD | +49 7621 41678600 | hans.ginz@unibas.ch |
| Switzerland | |
| University of Basel Hospital | Recruiting |
| Basel, Switzerland, CH-4031 | |
| Contact: Albert Urwyler, Professor Albert.Urwyler@usb.ch | |
| Contact: Hans F Ginz, MD +49 7621 4168296 hans.ginz@unibas.ch | |
| Principal Investigator: Albert Urwyler, Professor MD | |
| Study Director: | Albert Urwyler, Professor MD | Departments of Anaesthesia and Research, University of Basel Hospital, CH-4031, Switzerland |
Publications of Results:
| Responsible Party: | University Hospital, Basel, Switzerland |
| ClinicalTrials.gov Identifier: | NCT00735384 History of Changes |
| Other Study ID Numbers: |
134/02 P21/08//A05/08 ( Other Identifier: Else-Kröner-Fresenius-Stiftung 2008; SGAR / SSAR Fonds 2007, Schweizerische Muskelstiftung (SMS) 2016 ) |
| First Posted: | August 14, 2008 Key Record Dates |
| Last Update Posted: | January 16, 2018 |
| Last Verified: | January 2018 |
Keywords provided by University Hospital, Basel, Switzerland:
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sepsis critical illness muscle, skeletal myopathy isometric contraction |
intensive care units torque muscular atrophy malignant hyperthermia skin resistance |
Additional relevant MeSH terms:
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Sepsis Muscular Diseases Infection Systemic Inflammatory Response Syndrome Inflammation |
Pathologic Processes Musculoskeletal Diseases Neuromuscular Diseases Nervous System Diseases |