Critically-ill Clinical Trial
Official title:
Evaluation of Thermal-aided Muscle Activation in Intensive Care Unit (ICU) Patients - A PILOT Study
| Verified date | April 2013 |
| Source | Niveus Medical, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 5 |
| Est. completion date | February 2013 |
| Est. primary completion date | February 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Patient is enrolled within 60 hours of admission to the ICU - Patient expected to be subject to bedrest in the ICU for > 96 hours Exclusion Criteria: - 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 - 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| United States | Franklin Square Medical Center | Baltimore | Maryland |
| United States | Ohio State University Medical Center | Columbus | Ohio |
| United States | Baystate Medical Center | Springfield | Massachusetts |
| United States | University of Arizona Medical Center | Tucson | Arizona |
| United States | University of Massachusetts Medical Center | Worcester | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Niveus Medical, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Muscle Activation Effectiveness | Research team will assess whether or not visible or palpable muscle contractions can be activated in the target patient population. | Day of ICU Discharge, expected on average 5 days | No |
| Secondary | Muscle Mass | Muscle mass will be measured at several time points during the patient stay. | At enrollment, at ICU discharge (expected average days), at hospital discharge (expected average 10 days) | No |
| Secondary | Muscle Strength | Muscle strength will be assessed using MRC scales at various time points throughout the study | At enrollment, at ICU discharge (expected average days), at hospital discharge (expected average 10 days) | No |
| Secondary | Activities of Daily Living | The subject's proficiencies and independence in Activities of Daily Living will be assessed prior to hospital discharge. | At hospital discharge (expected average 10 days) | No |
| Secondary | 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. | At time of first ambulation (expected average 7 days), at hospital discharge (expected average 10 days) | No |
| Secondary | 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. | During timeframe when patient moves out of bed, expected on average 5 - 8 days into study | No |
| Secondary | Length of stay | The subject's length of stay will be recorded from chart review. | At end of study, expected on average after 10 days | No |
| Secondary | Ventilator Dependency | Chart review will be used to determine the number of ventilator days and the ventilator weaning time for each subject | During active ventilation and weaning period, expected to last on average 4 - 7 days per patient | No |