Respiratory FailureVTICUNCT01286610
Applicability and Safety of Vibration Therapy in Intensive Care Unit (ICU) Patients
A study testing ProMedVi Vibrosphere, schwa-medico MUSKELaktiv and Galileo Home Plus (ICU) in people with Respiratory Failure and Sepsis, run by Charite University, Berlin, Germany at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure, Sepsis, Brain Injury
- What is being tested?
- ProMedVi Vibrosphere, schwa-medico MUSKELaktiv and Galileo Home Plus (ICU)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2011to May 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- ProMedVi Vibrosphere, schwa-medico MUSKELaktiv, Galileo Home Plus (ICU)
- Keywords
- vibration, ICU, blood pressure, intracranial pressure, infection, indirect calorimetry
- Medical subject headings
- Respiratory Insufficiency, Sepsis, Brain Injuries, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProMedVi VibrosphereDevice
vibration therapy
schwa-medico MUSKELaktivDevice
Electrical muscle stimulation
Galileo Home Plus (ICU)Device
vibration therapy
| Study group | Role | What they receive |
|---|---|---|
| vibration therapy and electrical muscle stimulation | Other | Not described Receives: Device: ProMedVi Vibrosphere; Device: schwa-medico MUSKELaktiv; Device: Galileo Home Plus (ICU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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
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
Measured: 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
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.
Measured: Continuous record for app. 10 hours - therapy compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2011 (estimated)
- Study startFeb 2011
- Primary completionJan 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steffen Weber-Carstens, Charite University, Berlin, Germany
- Investigators
- Steffen Weber-Carstens, MD, Principal investigator, Dept. of Anesthesiology and Intensive Care Medicine, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01286610
- Sponsor's protocol ID
- KFO192/2-P3-Vibro-01
- Acronym
- VTICU
- Status last verified
- Feb 2017
- First submitted
- 28 Jan 2011
- Last updated
- 9 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28065165
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01286610
- Acronym / sponsor ID
- VTICU / KFO192/2-P3-Vibro-01
- Conditions
- Respiratory Failure, Sepsis, Brain Injury
- Keywords
- vibration, ICU, blood pressure, intracranial pressure, infection, indirect calorimetry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 31 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| vibration therapy and electrical muscle stimulation | Other | Device: ProMedVi Vibrosphere, Device: schwa-medico MUSKELaktiv, Device: Galileo Home Plus (ICU) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- immobilized icu patients:
- signed declaration of consent by the patient or its legal proxy
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProMedVi Vibrospherevibration therapy | Device | vibration therapy and electrical muscle stimulation |
| schwa-medico MUSKELaktivElectrical muscle stimulation | Device | vibration therapy and electrical muscle stimulation |
| Galileo Home Plus (ICU)vibration therapy | Device | vibration therapy and electrical muscle stimulation |
Primary outcome
Change of vital parameters as a measure of hemodynamic stability to show safety and tolerability
Time frame: Continuous record for 90 minutes - within 4 blood samples - vibration therapy compared to baseline
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.
4 secondary outcomes
Change of vital parameters as a measure of hemodynamic stability to show safety and tolerability.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: Continuous record for app. 10 hours - therapy compared to baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
- Results publication: PubMed 28065165Wollersheim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steffen Weber-Carstens, MD principal investigator
Dept. of Anesthesiology and Intensive Care Medicine, Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ProMedVi Vibrosphere, schwa-medico MUSKELaktiv and Galileo Home Plus (ICU) in people with Respiratory Failure and Sepsis, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of vital parameters as a measure of hemodynamic stability to show safety and tolerability (time frame: Continuous record for 90 minutes - within 4 blood samples - vibration therapy compared to baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01286610, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2017.