Critically-illNCT01552616
Safety and Performance of Muscle Activation for Critical Care Patients
A study testing Thermal-aided muscle activation in people with Critically-ill, run by Niveus Medical, Inc. at 5 sites in United States.
Trial summary
Critically-ill patients who have long stays in the hospital often face prolonged periods of bed rest. It is known that these patient develop profound weakness and debilitation. The effectiveness of existing muscle activation devices that could otherwise prevent the onset of debilitation in an immobilized patient has… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically-ill
- What is being tested?
- Thermal-aided muscle activation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 5 sitesUnited States
- Study dates
- Feb 2012to Feb 2013
- 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
- Patient is enrolled within 60 hours of admission to the ICU
- Patient expected to be subject to bedrest in the ICU for > 96 hours
Who cannot join
- Patient is age < 18 years at time of consent
- Patient is pregnant
- Patient is moribund
- Patient has an implanted pacemaker/defibrillator
- Patient has a documented diagnosis of epilepsy
- Patient has implanted femoral rods
Show all 15Show fewer
- Patient has leg or pelvic trauma that limits mobility
- Patient has recent trauma resulting in GCS < 5
- Patient lacks ability to walk without assistance prior to acute ICU admission
- Patient has neuromuscular disease or abnormalities
- Patient is morbidly obese (BMI > 40)
- Patient has a cognitive impairment or inability to follow commands prior to acute ICU admission
- Patient was transferred after > 48 hours at another acute care institution
- Enrollment in another investigational device or drug trial that could compromise the conduct or results of the study
- Evidence of disease or condition that, in the opinion of the physician, may compromise the conduct of or results of the study
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Franklin Square Medical Center
Baltimore, Maryland, 21237
Ohio State University Medical Center
Columbus, Ohio, 43210
Baystate Medical Center
Springfield, Massachusetts, 01199
University of Arizona Medical Center
Tucson, Arizona, 85724
University of Massachusetts Medical Center
Worcester, Massachusetts, 01655
About this study
Official title: Evaluation of Thermal-aided Muscle Activation in Intensive Care Unit (ICU) Patients - A PILOT Study
Critically-ill patients who have long stays in the hospital often face prolonged periods of bed rest. It is known that these patient develop profound weakness and debilitation. The effectiveness of existing muscle activation devices that could otherwise prevent the onset of debilitation in an immobilized patient has not been demonstrated widely in this cohort. It is hypothesized that using thermal methods to augment existing muscle activation techniques may demonstrate improved performance with no corresponding change in the safety profile.
- Conditions
- Critically-ill
- Being tested
- Thermal-aided muscle activation
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermal-aided muscle activationProcedure or surgery
Thermal-aided muscle activation therapy will be provided to patients twice daily. Treatment will begin within 24 hours of admission and continue until patients are significantly ambulatory.
| Study group | Role | What they receive |
|---|---|---|
| Activation Treatment | Experimental | Not described Receives: Procedure: Thermal-aided muscle activation |
| Usual Care | No intervention | This arm will not receive any study-motivated intervention. Subjects will receive usual care, but will participate in outcomes assessments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Activation Effectiveness
Research team will assess whether or not visible or palpable muscle contractions can be activated in the target patient population.
Measured: Day of ICU Discharge, expected on average 5 days
Secondary outcomes (7)
Muscle Mass
Muscle mass will be measured at several time points during the patient stay.
Measured: At enrollment, at ICU discharge (expected average days), at hospital discharge (expected average 10 days)
Muscle Strength
Muscle strength will be assessed using MRC scales at various time points throughout the study
Measured: At enrollment, at ICU discharge (expected average days), at hospital discharge (expected average 10 days)
Activities of Daily Living
The subject's proficiencies and independence in Activities of Daily Living will be assessed prior to hospital discharge.
Measured: At hospital discharge (expected average 10 days)
Six Minute Walk
A 6 minute walk test administered per ATS guidelines will be undertaken by all patients prior to discharge. When possible at least 2 six minute walk tests will be administered.
Measured: At time of first ambulation (expected average 7 days), at hospital discharge (expected average 10 days)
Time to ambulation
The time needed for a patient who had previously been subjected to bed rest to ambulate will be noted through chart review and nursing interviews.
Measured: During timeframe when patient moves out of bed, expected on average 5 - 8 days into study
Length of stay
The subject's length of stay will be recorded from chart review.
Measured: At end of study, expected on average after 10 days
Ventilator Dependency
Chart review will be used to determine the number of ventilator days and the ventilator weaning time for each subject
Measured: During active ventilation and weaning period, expected to last on average 4 - 7 days per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Why it stopped: Enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically-illStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Niveus Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Tidswell, MD, Principal investigator, Baystate Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01552616
- Sponsor's protocol ID
- NMSA
- Status last verified
- Apr 2013
- First submitted
- 20 Feb 2012
- Last updated
- 9 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Thermal-aided Muscle Activation in Intensive Care Unit (ICU) Patients - A PILOT Study
- ClinicalTrials.gov ID
- NCT01552616
- Acronym / sponsor ID
- NMSA
- Conditions
- Critically-ill
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Niveus Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 13 Mar 2012 (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.
Critically-ill patients who have long stays in the hospital often face prolonged periods of bed rest. It is known that these patient develop profound weakness and debilitation. The effectiveness of existing muscle activation devices that could otherwise prevent the onset of debilitation in an immobilized patient has not been demonstrated widely in this cohort. It is hypothesized that using thermal methods to augment existing muscle activation techniques may demonstrate improved performance with no corresponding change in the safety profile.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Activation Treatment | Experimental | Procedure: Thermal-aided muscle activation |
| Usual Care | No intervention | –This arm will not receive any study-motivated intervention. Subjects will receive usual care, but will participate in outcomes assessments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient is enrolled within 60 hours of admission to the ICU
- Patient expected to be subject to bedrest in the ICU for > 96 hours
Key exclusion criteria (15 listed)
- Patient is age < 18 years at time of consent
- Patient is pregnant
- Patient is moribund
- Patient has an implanted pacemaker/defibrillator
- Patient has a documented diagnosis of epilepsy
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 |
|---|---|---|
| Thermal-aided muscle activationThermal-aided muscle activation therapy will be provided to patients twice daily. Treatment will begin within 24 hours of admission and continue until patients are significantly ambulatory. | Procedure or surgery | Activation Treatment |
Primary outcome
Muscle Activation Effectiveness
Time frame: Day of ICU Discharge, expected on average 5 days
Research team will assess whether or not visible or palpable muscle contractions can be activated in the target patient population.
7 secondary outcomes
Muscle Mass
Time frame: At enrollment, at ICU discharge (expected average days), at hospital discharge (expected average 10 days)
Muscle Strength
Time frame: At enrollment, at ICU discharge (expected average days), at hospital discharge (expected average 10 days)
Activities of Daily Living
Time frame: At hospital discharge (expected average 10 days)
Six Minute Walk
Time frame: At time of first ambulation (expected average 7 days), at hospital discharge (expected average 10 days)
Time to ambulation
Time frame: During timeframe when patient moves out of bed, expected on average 5 - 8 days into study
Length of stay
Time frame: At end of study, expected on average after 10 days
Ventilator Dependency
Time frame: During active ventilation and weaning period, expected to last on average 4 - 7 days per patient
Results and safety
The study was stopped early (reason given: Enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2013.
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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.
Mark Tidswell, MD principal investigator
Baystate Medical Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thermal-aided muscle activation in people with Critically-ill, run by Niveus Medical, Inc. at 5 sites in United States.
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 2 inclusion and 15 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: stopped early, as of the sponsor's last update on 9 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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 was stopped early (reason given: Enrollment). Results are not available in the source record.
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?
Muscle Activation Effectiveness (time frame: Day of ICU Discharge, expected on average 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2013.