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

Primary Purpose

Respiratory Failure, Sepsis, Brain Injury

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
ProMedVi Vibrosphere
schwa-medico MUSKELaktiv
Galileo Home Plus (ICU)
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Respiratory Failure focused on measuring vibration, ICU, blood pressure, intracranial pressure, infection, indirect calorimetry

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Charite University, Berlin, Germany

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

vibration therapy and electrical muscle stimulation

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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
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.

Full Information

First Posted
January 28, 2011
Last Updated
February 7, 2017
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT01286610
Brief Title
Applicability and Safety of Vibration Therapy in Intensive Care Unit (ICU) Patients
Acronym
VTICU
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure, Sepsis, Brain Injury
Keywords
vibration, ICU, blood pressure, intracranial pressure, infection, indirect calorimetry

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
vibration therapy and electrical muscle stimulation
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
ProMedVi Vibrosphere
Intervention Description
vibration therapy
Intervention Type
Device
Intervention Name(s)
schwa-medico MUSKELaktiv
Intervention Description
Electrical muscle stimulation
Intervention Type
Device
Intervention Name(s)
Galileo Home Plus (ICU)
Intervention Description
vibration therapy
Primary Outcome Measure Information:
Title
Change of vital parameters as a measure of hemodynamic stability to show safety and tolerability
Description
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.
Time Frame
Continuous record for 90 minutes - within 4 blood samples - vibration therapy compared to baseline
Secondary Outcome Measure Information:
Title
Change of vital parameters as a measure of hemodynamic stability to show safety and tolerability.
Description
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.
Time Frame
Continuous record for 90 minutes - within 4 blood samples - vibration therapy compared to baseline
Title
Change in peripheral energy metabolism and hormonal state as a measure of muscle activation and systemic inflammatory reaction induced by vibration therapy.
Description
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.
Time Frame
Continuous record for 90 minutes - within 4 blood samples - vibration therapy compared to baseline
Title
Change in peripheral energy metabolism and hormonal state as measure of muscle activation and systemic inflammatory reaction induced by vibration therapy
Description
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
Time Frame
Continuous record for 90 minutes - within 4 blood samples - vibration therapy compared to baseline
Title
Change in systemic and local energy metabolism as measure of muscle activation by vibration therapy and electrical muscle stimulation
Description
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.
Time Frame
Continuous record for app. 10 hours - therapy compared to baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steffen Weber-Carstens, MD
Organizational Affiliation
Dept. of Anesthesiology and Intensive Care Medicine, Charite University, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charite University, Berlin, Germany
City
Berlin
ZIP/Postal Code
13353
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
28065165
Citation
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.
Results Reference
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Applicability and Safety of Vibration Therapy in Intensive Care Unit (ICU) Patients

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