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Applicability and Safety of Vibration Therapy in Intensive Care Unit (ICU) Patients (VTICU)

This study is currently recruiting participants.
Verified January 2012 by Charite University, Berlin, Germany
Sponsor:
Information provided by (Responsible Party):
Steffen Weber-Carstens, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01286610
First received: January 28, 2011
Last updated: January 2, 2012
Last verified: January 2012
History of Changes
  Purpose

Vibration therapy is used for different indications in rehabilitation and sports medicine. So far, vibration therapy has not been investigated within the ICU setting. The investigators created this setting to show safety and applicability of vibration therapy in ICU patients. 30 patients will be stimulated by vibration therapy on two separate days during their ICU stay. Three collectives of equal size will be observed: One with patients on mechanical ventilation without signs of infection or suspected intracranial pressure problems, a second one with patients on mechanical ventilation in addition to signs of systemic inflammation but absence of suspected intracranial pressure problems, and a third one with patients on mechanical ventilation, signs of systemic inflammation in addition to presence of controlled intracranial pressure problems. Typical parameters of hemodynamic status, intracranial pressure and energy metabolism will be recorded for a defined period of time before, during and after vibration therapy itself. Vibration therapy will be combined with protocol based physiotherapy.

Our aim is to show the effects of vibration therapy in ICU patients and its safe applicability.

ADDITION 06th of May 2011: Additionally we will perform euglycaemic hyperinsulinemic clamp and intervention on one day of ICU stay in 20 patients. Under clamp conditions we will perform a vibration therapy (ProMedVi Vibrosphere™) on patients' legs. On top we will perform electrical muscle stimulation (schwa-medico, MUSKELaktiv™) on one ventral upper leg, randomized chosen. Measuring the local skeletal muscle metabolism will be done by microdialysis in Vastus lateralis on both sides - comparing vibration therapy and vibration therapy combined with electrical muscle stimulation.


Condition Intervention
Respiratory Failure
Sepsis
Brain Injury
 Device: ProMedVi Vibrosphere
Device: schwa-medico MUSKELaktiv
Device: Galileo Home Plus (ICU)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Application of Vibration Therapy as a Measure of Muscle Activation in ICU Patients and Its Effect on Hemodynamics, Intracranial Pressure as Well as Energy Metabolism

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Change of vital parameters as a measure of hemodynamic stability to show safety and tolerability [ Time Frame: Continuous record for 90 minutes - within 4 blood samples - vibration therapy compared to baseline ] [ Designated as safety issue: Yes ]
    Changes in heart rate, arterial blood pressure, saturation of peripheral pulse oximetry, intracranial pressure, mechanical ventilation parameters, electrolytes, blood sugar and lactate levels, blood pH, PICCO-parameters, body temperature as well as pO2 und pCO2 partial pressure.


Secondary Outcome Measures:
  • Change of vital parameters as a measure of hemodynamic stability to show safety and tolerability. [ Time Frame: Continuous record for 90 minutes - within 4 blood samples - vibration therapy compared to baseline ] [ Designated as safety issue: Yes ]
    Change in heart rate, arterial blood pressure, saturation of peripheral pulse oximetry, intracranial pressure, mechanical ventilation parameters, electrolyte, blood sugar and lactate levels, blood pH, PICCO-parameters, body temperature as well as pO2 und pCO2 partial pressure.

  • Change in peripheral energy metabolism and hormonal state as a measure of muscle activation and systemic inflammatory reaction induced by vibration therapy. [ Time Frame: Continuous record for 90 minutes - within 4 blood samples - vibration therapy compared to baseline ] [ Designated as safety issue: No ]
    Change in Parameters of indirect calorimetry, circulating IGF-1, IGFBP-1, IGFBP-3, IL-6, IL-10, insulin, cortisol, blood sugar and lactate levels, blood pH, PICCO-parameters, body temperature as well as pO2 und pCO2 partial pressure.

  • Change in peripheral energy metabolism and hormonal state as measure of muscle activation and systemic inflammatory reaction induced by vibration therapy [ Time Frame: Continuous record for 90 minutes - within 4 blood samples - vibration therapy compared to baseline ] [ Designated as safety issue: No ]
    Change in Parameters of indirect calorimetry, circulating IGF-1, IGFBP-1, IGFBP-3, IL-6, IL-10, insulin, cortisol, blood sugar and lactate levels, blood pH, PICCO-parameters, body temperature as well as pO2 und pCO2 partial pressure

  • Change in systemic and local energy metabolism as measure of muscle activation by vibration therapy and electrical muscle stimulation [ Time Frame: Continuous record for app. 10 hours - therapy compared to baseline ] [ Designated as safety issue: No ]
    Change in Parameters of indirect calorimetry, circulating IGF-1, IGFBP-1, IGFBP-3, IL-6, IL-10, insulin, cortisol, blood sugar and lactate levels, blood pH, PICCO-parameters, body temperature as well as pO2 und pCO2 partial pressure for systemic energy metabolism. For local skeletal muscle metabolism we will measure glucose, lactate, pyruvate, urea and glycerol by microdialyses technic.


Estimated Enrollment: 30
Study Start Date: February 2011
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
vibration therapy and electrical muscle stimulation Device: ProMedVi Vibrosphere
vibration therapy
Device: schwa-medico MUSKELaktiv
Electrical muscle stimulation
Device: Galileo Home Plus (ICU)
vibration therapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • immobilized icu patients:

    • with mechanical ventilation without signs of infection
    • with mechanical ventilation and SIRS or sepsis
    • with mechanical ventilation, with controlled elevated intracranial pressure and with or without SIRS or sepsis
  • signed declaration of consent by the patient or its legal proxy

Exclusion Criteria:

  • age < 18 years old
  • already known neuromuscular disease
  • missing declaration of consent by the patient or its legal proxy
  • implanted heart pacemaker or defibrillator
  • pregnancy
  • acute thrombosis
  • not yet healed fracture ad the part of the body which will be trained
  • implants ad the part of the body which will be trained
  • a nearly done ophthalmic surgery
  • acute disc prolapse
  • infaust prognosis, that means death is expected into the next couple of hours, although maximum therapy is done
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01286610

Contacts
Contact: Steffen Weber-Carstens, MD steffen.weber-carstens@charite.de
Contact: Tobias Wollersheim, MD tobias.wollersheim@charite.de

Locations
Germany
Charite University, Berlin, Germany Recruiting
Berlin, Germany, 13353
Contact: Steffen Weber-Carstens, MD         steffen.weber-carstens@charite.de    
Contact: Tobias Wollersheim, MD         tobias.wollersheim@charite.de    
Sub-Investigator: Tobias Wollersheim, MD            
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Steffen Weber-Carstens, MD Dept. of Anesthesiology and Intensive Care Medicine, Charite University, Berlin, Germany
  More Information

No publications provided

Responsible Party: Steffen Weber-Carstens, Dr. med. Steffen Weber-Carstens, Dept. of Anesthesiology and Intensive Care Medicine, Charite University, Berlin, Germany., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01286610     History of Changes
Other Study ID Numbers: KFO192/2-P3-Vibro-01
Study First Received: January 28, 2011
Last Updated: January 2, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
vibration
ICU
blood pressure
 intracranial pressure
infection
indirect calorimetry

Additional relevant MeSH terms:
Sepsis
Brain Injuries
Respiratory Insufficiency
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013