Muscle Force Assessment in the Intensive Care Unit Environment

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by University Hospital, Basel, Switzerland.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University of Minnesota - Clinical and Translational Science Institute
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00735384
First received: August 13, 2008
Last updated: March 19, 2012
Last verified: March 2012
  Purpose

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.


Condition
Sepsis
Malignant Hyperthermia

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • changes in skeletal muscle force values [ Time Frame: during critical ill state, and 1 and 2 months after ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
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)
Groups/Cohorts
A ICU patients
Patients on intensive care units with severe illnesses (sepsis, ARDS, etc.)
B
Patients with a familiar disposition towards Malignant Hyperthermia

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 with a previous history of a Malignant Hyperthermia episode or family members with disposition towards MH

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00735384

Contacts
Contact: Albert Urwyler, Professor MD +4161 265 2525 aurwyler@uhbs.ch
Contact: Hans F Ginz, MD +49 7621 41678600 ginz.hans-friedrich@klinloe.de

Locations
Switzerland
University of Basel Hospital Recruiting
Basel, Switzerland, CH-4031
Contact: Albert Urwyler, Professor       aurwyler@uhbs.ch   
Contact: Hans F Ginz, MD    +49 7621 41678600    ginz.hans-friedrich@klinloe.de   
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

Publications:
Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT00735384     History of Changes
Other Study ID Numbers: 134/02, P21/08//A05/08
Study First Received: August 13, 2008
Last Updated: March 19, 2012
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital, Basel, Switzerland:
sepsis
critical illness
muscle, skeletal
isometric contraction
intensive care units
torque
muscular atrophy
malignant hyperthermia
skin resistance

Additional relevant MeSH terms:
Fever
Malignant Hyperthermia
Sepsis
Body Temperature Changes
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Infection
Systemic Inflammatory Response Syndrome
Inflammation

ClinicalTrials.gov processed this record on April 17, 2014