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

Sepsis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01286610
• Other study ID #: KFO192/2-P3-Vibro-01
• Status: Completed
• Phase: N/A
• First received: January 28, 2011
• Last updated: February 7, 2017
• Start date: February 2011
• Est. completion date: May 2012

Study information

• Verified date: February 2017
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injury
• Respiratory Failure
• Respiratory Insufficiency
• Sepsis

Intervention

Device:
• ProMedVi Vibrosphere
vibration therapy
• schwa-medico MUSKELaktiv
Electrical muscle stimulation
• Galileo Home Plus (ICU)
vibration therapy

Locations

Country	Name	City	State
Germany	Charite University, Berlin, Germany	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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