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

NCT01286610 | Completed DMC

• 1 other identifier: KFO192/2-P3-Vibro-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Failure; Sepsis; Brain Injury

Keywords

vibration; ICU; blood pressure; intracranial pressure; infection; indirect calorimetry

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change of vital parameters as a measure of hemodynamic stability to show safety and tolerability.

  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.

  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

  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

  Continuous record for app. 10 hours - therapy compared to baseline

Study Arms (1)

vibration therapy and electrical muscle stimulation

OTHER

Device: ProMedVi Vibrosphere; Device: schwa-medico MUSKELaktiv; Device: Galileo Home Plus (ICU)

Interventions

ProMedVi Vibrosphere DEVICE

vibration therapy

vibration therapy and electrical muscle stimulation

schwa-medico MUSKELaktiv DEVICE

Electrical muscle stimulation

vibration therapy and electrical muscle stimulation

Galileo Home Plus (ICU) DEVICE

vibration therapy

vibration therapy and electrical muscle stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charite University, Berlin, Germany

Berlin, 13353, Germany

Location

Related 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):9. doi: 10.1186/s13054-016-1576-y.

  PMID: 28065165 RESULT

MeSH Terms

Conditions

Respiratory Insufficiency; Sepsis; Brain Injuries; Infections

Condition Hierarchy (Ancestors)

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

Study Officials

• Steffen Weber-Carstens, MD

  Dept. of Anesthesiology and Intensive Care Medicine, Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med. Steffen Weber-Carstens, Dept. of Anesthesiology and Intensive Care Medicine, Charite University, Berlin, Germany.

Study Record Dates

• First Submitted: January 28, 2011
• First Posted: January 31, 2011
• Study Start: February 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: May 1, 2012
• Last Updated: February 9, 2017

Record last verified: 2017-02

Locations

DE (1)