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NCT Number: NCT01286610

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

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.

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Key information

Conditions

Respiratory Failure Brain Diseases Brain Injuries Brain Injury Central Nervous System Diseases Craniocerebral Trauma Infections Inflammation Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Sepsis Systemic Inflammatory Response Syndrome Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charite University, Berlin, Germany

Berlin, 13353, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ProMedVi Vibrosphere

Device

vibration therapy

schwa-medico MUSKELaktiv

Device

Electrical muscle stimulation

Galileo Home Plus (ICU)

Device

vibration therapy

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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.

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study 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

Acronym: VTICU

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jan 31, 2011
Registry last updated
Feb 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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