TerminatedNot Applicable

Neuromuscular Electrical Stimulation in ICU Patients

Stopped: Due to the pandemic we were unable to recruit patients from the hospital

Brazil56 participantsStarted 2022-03-01

Plain-language summary

The aim of the present study is to evaluate the effects of neuromuscular electrical stimulation (NMES) combined with conventional physiotherapy (Experimental Group), compared to conventional physiotherapy only (Control Group) in critically ill Intensive Care Unit (ICU) patients, by means of a randomized controlled clinical trial. The investigators expect that the NMES program will be able to reduce muscle structure and function losses compared to control group, and will improve muscle quality faster, will reduce the ventilation time and the total time spent at the ICU, as well as improve functionality of these patients. In addition, the researchers expect to understand which mechanisms determine such adaptations in the musculoskeletal system of these patients.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients with any clinical condition hospitalized in the ICU, which are monitored by the Physiotherapy Service: * Cerebrovascular diseases * Other bacterial diseases * Circulatory and respiratory diseases * Digestive and abdominal diseases * Liver diseases * Time between the patient's ICU entry and the onset of the NMES intervention less than one week. Patients may be in mechanical ventilation, non-invasive ventilation, oxygen therapy or oxygen ambient ventilation (no ventilatory add). Patients re-admitted to the ICU within the same hospitalization period (i.e., did not leave the hospital) may also be included, as well as patients with previous tracheostomy. Exclusion Criteria: * Previously diagnosed neuromuscular diseases: * ALS * Guillain Barre * Chronic stroke * TRM * End-stage malignant disease * Lower limbs' amputation * Body mass index above 40 kg/m2 * Cachexia (defined as the presence of chronic disease and weight loss ≥ 5% in a period shorter than 12 months or BMI \< 20 kg/m2, associated with at least three of the following criteria: (1) decreased muscle strength; (2) fatigue; (3) anorexia; (4) reduction of fat free mass index; and (5) biochemical abnormalities such as inflammation, anemia or reduction of serum albumin concentration). * Lesions on the skin at the electrode placement and/or dynamometer support points * Post-operative transplantation * Patients using a neuromuscular blocker * Hemodynamic instability (nora \> 10; ABCDE criteria)…

What they're measuring

Total ICU time

Timeframe: Immediately after each patient discharge from the ICU (7 to 15 days after entry at the ICU, on average).

Mechanical ventilation time

Timeframe: Immediately after each patient mechanical ventilation release (2 to 5 days from intubation start, on average).

Weaning time

Timeframe: Immediately after each patient discharge from the ICU (7 to 15 days after entry at the ICU, on average).

Change in knee extensor evoked force

Timeframe: Change from the patient ICU admission to immediately before ICU discharge (e.g., from day 1 to day 7-15, on average).

Knee extensor maximal voluntary isometric contraction

Timeframe: Immediately before each patient ICU discharge (7 to 15 days after admission, on average).

Knee extensor muscle quality: Real-time ultrasound 9 MHz frequency

Timeframe: Immediately after each patient ICU admission and immediately before ICU discharge (7 to 15 days on average).

Rectus femoris cross-sectional area

Timeframe: Immediately after each patient ICU admission and immediately before ICU discharge (7 to 15 days on average).

Trial details

NCT IDNCT04332263

SponsorFederal University of Rio Grande do Sul

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-03-01

View on ClinicalTrials.gov More Intensive Care Unit Acquired Weakness trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Total ICU time

Timeframe: Immediately after each patient discharge from the ICU (7 to 15 days after entry at the ICU, on average).

Mechanical ventilation time

Timeframe: Immediately after each patient mechanical ventilation release (2 to 5 days from intubation start, on average).

Weaning time

Timeframe: Immediately after each patient discharge from the ICU (7 to 15 days after entry at the ICU, on average).

Change in knee extensor evoked force

Timeframe: Change from the patient ICU admission to immediately before ICU discharge (e.g., from day 1 to day 7-15, on average).

Knee extensor maximal voluntary isometric contraction

Timeframe: Immediately before each patient ICU discharge (7 to 15 days after admission, on average).

Knee extensor muscle quality: Real-time ultrasound 9 MHz frequency

Timeframe: Immediately after each patient ICU admission and immediately before ICU discharge (7 to 15 days on average).

Rectus femoris cross-sectional area

Timeframe: Immediately after each patient ICU admission and immediately before ICU discharge (7 to 15 days on average).