Muscle Force Assessment in the Intensive Care Unit Environment
The primary aim of the project is to apply the redesigned non-invasive stimulated muscle force assessment system to intensive care unit patients. The investigators will use this new methodology of force assessment to phenotype patients weakness during their illnesses and recovery periods. This new system will be evaluated until the year 2012. The investigators will measure parameters of isometric skeletal muscle force. An anonymized data bank of force values will be created. Additionally, this methodology will be applied to patients which undergo clinical investigations at our Swiss Malignant Hyperthermia Centre to look for interindividual differences in muscles forces.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Application of Methodology of Non-invasive Stimulated Muscle Force Assessment to Long-term ICU Patients to Characterize Their Muscle Weakness and to Patients With Malignant Hyperthermia - Extension of the Study Protocol: 2008 to 2012|
- changes in skeletal muscle force values [ Time Frame: during critical ill state, and 1 and 2 months after ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||September 2006|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
A ICU patients
Patients on intensive care units with severe illnesses (sepsis, ARDS, etc.)
Patients with a familiar disposition towards Malignant Hyperthermia
A force measuring system similar to one employed in previous studies will be redesigned with light-weight plastics, a new stimulator system, and an extendable leg support system (like using aluminium crutches). An electromyograph and an ultrasound / infrared probe to determine muscle tissue perfusion will be combined. This new, small, light and portable measurement system accurately measures patients' muscle forces and tissue perfusion. The system produces repeatable results. Over a time period of 5 years, this new system will be applied to ICU patients 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 weekly, and subsequently the individualized curves will be determined. Dorsiflexor muscle group tissue perfusion will be measured and 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. 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.
Additionally, skin resistances of sepsis patients and controls will by determined employing a twitch stimulator and an oscilloscope. Data are required to redesign the new stimulation unit of the muscle force measuring system.
|Contact: Albert Urwyler, Professor MD||+4161 265 email@example.com|
|Contact: Hans F Ginz, MD||+49 7621 firstname.lastname@example.org|
|University of Basel Hospital||Recruiting|
|Basel, Switzerland, CH-4031|
|Contact: Albert Urwyler, Professor email@example.com|
|Contact: Hans F Ginz, MD +49 7621 41678600 firstname.lastname@example.org|
|Principal Investigator: Albert Urwyler, Professor MD|
|Study Director:||Albert Urwyler, Professor MD||Departments of Anaesthesia and Research, University of Basel Hospital, CH-4031, Switzerland|