Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02247895
Other study ID # 062014
Secondary ID 14-0237-F3R
Status Terminated
Phase N/A
First received
Last updated
Start date December 2016
Est. completion date February 2018

Study information

Verified date June 2020
Source University of Kentucky
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Patients who are admitted to the intensive care unit and require mechanical ventilation frequently develop profound respiratory and limb muscle weakness. Studies show that the development of weakness during the ICU stay results in poor outcomes. Currently there are no treatments for this muscle weakness, but it has been suggested that this weakness might improve with physical therapy. Electrical stimulation is a method to provide direct stimulation to the muscles potentially enhancing function and improving strength. The purpose of this study is to test the hypothesis that neuromuscular electrical stimulation of the quadriceps muscle will improve muscle strength in patients who are critically ill on mechanical ventilation.


Description:

The basic study design is to:

1. Obtain informed consent from patient or the patients LAR

2. Randomize subjects to treatment with either:

1. Sham therapy, consisting of bilateral placement of Niveus Medical Muscle Stimulation System 110 electrodes for 30 minutes twice daily without activation of the electrical circuitry of the unit, or

2. Active therapy, using the Niveus Medical Muscle Stimulation System 110 electrodes to actively produce a rhythmic quadriceps contraction for 30 minutes twice daily

3. Measure magnetic stimulated quadriceps twitch (QuadTw) strength bilaterally as well as ultrasound assessment of quadriceps size

4. Continue sham or active treatment daily for 7 days for a total of 14 sessions

5. Repeat measurements of magnetic stimulated QuadTw strength and ultrasound assessment of quadriceps size on Day 8 or before Day 8 if the subject is to be discharged from the hospital prior to the allotted duration of sham or active treatment

6. Functional measurement of the patient using the Functional Status Score for the ICU (FSS-ICU) at the end of the treatment period or upon discharge

7. A member of the research team will visit the subject until hospital discharge and will record total duration (days) of mechanical ventilation, duration (days) of mechanical ventilation following study entry, duration of ICU stay, ventilator weaning time (days measured from time of first spontaneous breathing trial to extubation), and total duration (days) of hospitalization

8. The investigators will also review each subject's medical record on entry into the study to obtain demographic information including the following: age, sex, diagnoses, medications, reason for institution of mechanical ventilation, vital signs at the time of the initial visit, bedside parameters of mechanical ventilation use (including mode of ventilation, duration of ventilation, level of oxygen, breath volume and rate, % triggered breaths), most recent arterial blood gas values, and chest radiograph readings at the time of the initial visit. The investigators will also record the subject's weight, BMI and total intake and output values since admission to the ICU. In addition, investigators will monitor each subject's progress in the ICU daily by reviewing the subject's medical record and recording the clinical parameters as well as recording daily weights and total intake and output. These parameters will also be assessed until the time that the patient is discharged from the ICU. In addition, the investigators will record and note all physical therapy and occupational therapy sessions that the subject receives as part of the standard of care in the ICU and in the hospital up until the time of discharge. In the University of Kentucky hospital, occupational therapy records the Barthel Index at each session which uses a scale of 0-100 to assess an individual's functional independence when performing activities of daily living (ADLs). Physical therapy assesses functional status using Kansas University Hospital Physical Therapy Acute Care Functional Outcomes, which also assesses functional status in the categories of bed mobility, transfer, gait and walking distance.


Recruitment information / eligibility

Status Terminated
Enrollment 2
Est. completion date February 2018
Est. primary completion date February 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Acute respiratory failure requiring mechanical ventilation

Exclusion Criteria:

- Attending physician on service determines that patient too unstable to tolerate measurements

- Patient requires > 15mcg/min norepinephrine or > 15mg/kg/min of dopamine.

- Fraction of inspired oxygen > 80% or positive end expiratory pressure > 15 cm H20 requirements.

- Cardiac pacemaker or implanted defibrillator.

- Neuromuscular blocking agents delivered within 48 hours of preceding testing.

- Existing neuromuscular disease.

- Profound uncorrectable hypokalemia (< 2.5) OR hypophosphatemia (< 1.0)

- Acute lower extremity deep vein thrombosis

- Pregnancy

- Prisoner

- Institutionalized patient

- If primary attending determines that patient is terminal and will likely have care withdrawn within 7 days

- Do not resuscitate order

- Body mass index > 40

- Patients requiring mechanical ventilation more than 4 days prior to study entry

Study Design


Intervention

Device:
Sham Treatment
Subjects will undergo the same protocol as the treatment group except no electrical stimulation will be applied.
Electrical stimulation
Two thirty minute sessions of neuromuscular electrical stimulation applied to both quadriceps for seven days for a total of 14 treatments

Locations

Country Name City State
United States University of Kentucky Medical Center Lexington Kentucky

Sponsors (1)

Lead Sponsor Collaborator
Gerald Supinski

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Rectus Femorus thickness Rectus femorus thickness will be measured using ultrasound at baseline (study entry) and on Day 8 of study after either sham treatment or neuromuscular stimulation Day 8
Primary Technical Feasibility, that is ability to complete therapy sessions Percentage of patients who completed treatment with the device Discharge from ICU, Average 7-10 days
Secondary Total ICU length of stay Average 7-10 days Discharge from ICU, Average 7-10 days
Secondary Hospital Length of Stay Average 14-21 days Hospital discharge, Average 14-21 days
Secondary Functional Status Score for ICU Average 7-10 days after study entry ICU discharge, Average 7-10 days after study entry
Secondary Duration of mechanical ventilation after study entry Average 4-10 days Until patient is successfully weaned from mechanical ventilation, Average 4-10 days
Secondary Change in quadriceps twitch force generation Quadriceps twitch force generation will be measured using magnetic stimulation of each femoral nerve and compared to measurements obtained at the time of study entry (baseline-prior to randomization) Baseline (prior to Treatment) and Day 8
See also
  Status Clinical Trial Phase
Completed NCT04551508 - Delirium Screening 3 Methods Study
Recruiting NCT06037928 - Plasma Sodium and Sodium Administration in the ICU
Completed NCT03671447 - Enhanced Recovery After Intensive Care (ERIC) N/A
Recruiting NCT03941002 - Continuous Evaluation of Diaphragm Function N/A
Recruiting NCT04674657 - Does Extra-Corporeal Membrane Oxygenation Alter Antiinfectives Therapy Pharmacokinetics in Critically Ill Patients
Completed NCT04239209 - Effect of Intensivist Communication on Surrogate Prognosis Interpretation N/A
Completed NCT05531305 - Longitudinal Changes in Muscle Mass After Intensive Care N/A
Terminated NCT03335124 - The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock Phase 4
Completed NCT02916004 - The Use of Nociception Flexion Reflex and Pupillary Dilatation Reflex in ICU Patients. N/A
Recruiting NCT05883137 - High-flow Nasal Oxygenation for Apnoeic Oxygenation During Intubation of the Critically Ill
Completed NCT04479254 - The Impact of IC-Guided Feeding Protocol on Clinical Outcomes in Critically Ill Patients (The IC-Study) N/A
Recruiting NCT04475666 - Replacing Protein Via Enteral Nutrition in Critically Ill Patients N/A
Not yet recruiting NCT04538469 - Absent Visitors: The Wider Implications of COVID-19 on Non-COVID Cardiothoracic ICU Patients, Relatives and Staff
Not yet recruiting NCT04516395 - Optimizing Antibiotic Dosing Regimens for the Treatment of Infection Caused by Carbapenem Resistant Enterobacteriaceae N/A
Withdrawn NCT04043091 - Coronary Angiography in Critically Ill Patients With Type II Myocardial Infarction N/A
Recruiting NCT02922998 - CD64 and Antibiotics in Human Sepsis N/A
Recruiting NCT02989051 - Fluid Restriction Keeps Children Dry Phase 2/Phase 3
Completed NCT03048487 - Protein Consumption in Critically Ill Patients
Completed NCT02899208 - Can an Actigraph be Used to Predict Physical Function in Intensive Care Patients? N/A
Recruiting NCT02163109 - Oxygen Consumption in Critical Illness