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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01286610
First Posted: January 31, 2011
Last Update Posted: February 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Steffen Weber-Carstens, Charite University, Berlin, Germany
  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: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Further study details as provided by Steffen Weber-Carstens, 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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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.


Enrollment: 20
Study Start Date: February 2011
Study Completion Date: May 2012
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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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): NCT01286610


Locations
Germany
Charite University, Berlin, Germany
Berlin, Germany, 13353
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

Publications:
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
First Submitted: January 28, 2011
First Posted: January 31, 2011
Last Update Posted: February 9, 2017
Last Verified: February 2017

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

Additional relevant MeSH terms:
Brain Injuries
Respiratory Insufficiency
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Respiration Disorders
Respiratory Tract Diseases