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

NCT ID: NCT01286610

Last Updated: 2017-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2012-05-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

vibration therapy and electrical muscle stimulation

Group Type: OTHER

ProMedVi Vibrosphere

Intervention Type: DEVICE

vibration therapy

schwa-medico MUSKELaktiv

Intervention Type: DEVICE

Electrical muscle stimulation

Galileo Home Plus (ICU)

Intervention Type: DEVICE

vibration therapy

Interventions

ProMedVi Vibrosphere

vibration therapy

Intervention Type: DEVICE

schwa-medico MUSKELaktiv

Electrical muscle stimulation

Intervention Type: DEVICE

Galileo Home Plus (ICU)

vibration therapy

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Steffen Weber-Carstens

Dr. med. Steffen Weber-Carstens, Dept. of Anesthesiology and Intensive Care Medicine, Charite University, Berlin, Germany.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steffen Weber-Carstens, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Charite University, Berlin, Germany

Berlin, , Germany

Countries

Germany

References

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.

Reference Type: RESULT

PMID: 28065165 (View on PubMed)

Other Identifiers

KFO192/2-P3-Vibro-01

Identifier Type: -

Identifier Source: org_study_id