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

Study Description

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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
Sepsis; Primary Myopathies

Detailed Description:

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 Design

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Groups and Cohorts

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
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

Outcome Measures

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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 ]

Eligibility Criteria

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Primary care clinic

Criteria

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.

Contacts and Locations

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Albert Urwyler, Professor MD	+4161 265 2525	Albert.Urwyler@usb.ch
Contact: Hans F Ginz, MD	+49 7621 41678600	hans.ginz@unibas.ch

Locations

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

Sponsors and Collaborators

University Hospital, Basel, Switzerland

University of Minnesota - Clinical and Translational Science Institute

Investigators

Study Director:	Albert Urwyler, Professor MD	Departments of Anaesthesia and Research, University of Basel Hospital, CH-4031, Switzerland

More Information

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Ginz HF, Iaizzo PA, Urwyler A, Pargger H. Use of non-invasive-stimulated muscle force assessment in long-term critically ill patients: a future standard in the intensive care unit? Acta Anaesthesiol Scand. 2008 Jan;52(1):20-7. Epub 2007 Aug 20.

Ginz HF, Bandschapp O, Urwyler A, Girard T, Iaizzo PA. Tissue oedema is not associated with skeletal muscle weakness in septic patients. Acta Anaesthesiol Scand. 2010 Aug;54(7):904. doi: 10.1111/j.1399-6576.2010.02257.x.

Durfee WK, Young JR, Ginz HF. Inter-electrode tissue resistance is not affected by tissue oedema when electrically stimulating the lower limb of sepsis patients. J Med Eng Technol. 2014 May;38(4):227-31. doi: 10.3109/03091902.2014.904451.

Ginz HF, Iaizzo PA, Schweikert K, Durfee WK. Isometric skeletal muscle force measurement in primary myopathies. Muscle Nerve. 2016 Jun;53(6):913-7. doi: 10.1002/mus.24954. Epub 2016 Feb 8.

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
Last Update Posted:	January 16, 2018
Last Verified:	January 2018

Keywords provided by University Hospital, Basel, Switzerland:

sepsis; critical illness; muscle, skeletal; myopathy; isometric contraction	intensive care units; torque; muscular atrophy; malignant hyperthermia; skin resistance

Additional relevant MeSH terms:

Sepsis; Muscular Diseases; Infection; Systemic Inflammatory Response Syndrome; Inflammation	Pathologic Processes; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases