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

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

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.

Study Overview

• Status: Completed
• Conditions: Sepsis; Brain Injury; Respiratory Failure
• Intervention / Treatment: Device: ProMedVi Vibrosphere; Device: schwa-medico MUSKELaktiv; Device: Galileo Home Plus (ICU)

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Charite University, Berlin, Germany

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of vital parameters as a measure of hemodynamic stability to show safety and tolerability	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.	Continuous record for 90 minutes - within 4 blood samples - vibration therapy compared to baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of vital parameters as a measure of hemodynamic stability to show safety and tolerability.	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.	Continuous record for 90 minutes - within 4 blood samples - vibration therapy compared to baseline
Change in peripheral energy metabolism and hormonal state as a measure of muscle activation and systemic inflammatory reaction induced by vibration therapy.	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.	Continuous record for 90 minutes - within 4 blood samples - vibration therapy compared to baseline
Change in peripheral energy metabolism and hormonal state as measure of muscle activation and systemic inflammatory reaction induced by vibration therapy	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	Continuous record for 90 minutes - within 4 blood samples - vibration therapy compared to baseline
Change in systemic and local energy metabolism as measure of muscle activation by vibration therapy and electrical muscle stimulation	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.	Continuous record for app. 10 hours - therapy compared to baseline

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Principal Investigator: Steffen Weber-Carstens, MD, Dept. of Anesthesiology and Intensive Care Medicine, Charite University, Berlin, Germany

Publications and helpful links

General Publications

• Wollersheim T, Haas K, Wolf S, Mai K, Spies C, Steinhagen-Thiessen E, Wernecke KD, Spranger J, Weber-Carstens S. Whole-body vibration to prevent intensive care unit-acquired weakness: safety, feasibility, and metabolic response. Crit Care. 2017 Jan 9;21(1):9. doi: 10.1186/s13054-016-1576-y.

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: January 28, 2011
• First Submitted That Met QC Criteria: January 28, 2011
• First Posted (Estimate): January 31, 2011

Study Record Updates

• Last Update Posted (Estimate): February 9, 2017
• Last Update Submitted That Met QC Criteria: February 7, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: ICU; infection; blood pressure; intracranial pressure; vibration; indirect calorimetry
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Respiratory Insufficiency
• Other Study ID Numbers: KFO192/2-P3-Vibro-01