Clinical trial NCT01286610: Applicability and Safety of Vibration Therapy in Intensive Care Unit (ICU) Patients
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
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Failure
Sepsis
Brain Injury
Keywords: vibration
ICU
blood pressure
intracranial pressure
infection
indirect calorimetry
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2011-01-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Change of vital parameters as a measure of hemodynamic stability to show safety and tolerability
timeFrame: Continuous record for 90 minutes - within 4 blood samples - vibration therapy compared to baseline
Secondary outcomes:
measure: Change of vital parameters as a measure of hemodynamic stability to show safety and tolerability.
timeFrame: Continuous record for 90 minutes - within 4 blood samples - vibration therapy compared to baseline
measure: Change in peripheral energy metabolism and hormonal state as a measure of muscle activation and systemic inflammatory reaction induced by vibration therapy.
timeFrame: Continuous record for 90 minutes - within 4 blood samples - vibration therapy compared to baseline
measure: Change in peripheral energy metabolism and hormonal state as measure of muscle activation and systemic inflammatory reaction induced by vibration therapy
timeFrame: Continuous record for 90 minutes - within 4 blood samples - vibration therapy compared to baseline
measure: Change in systemic and local energy metabolism as measure of muscle activation by vibration therapy and electrical muscle stimulation
timeFrame: Continuous record for app. 10 hours - therapy compared to baseline
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite University, Berlin, Germany
Study officials:
affiliation: Dept. of Anesthesiology and Intensive Care Medicine, Charite University, Berlin, Germany
name: Steffen Weber-Carstens, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.