Clinical trial NCT03815994: Neuromuscular Electrical Stimulation in Critically Ill Patients.
Official title: Effects of Physical Therapy With Neuromuscular Electrical Stimulation in Critically Ill Patients: a Randomised Crossover Clinical Trial Protocol.
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Critical Care
Rehabilitation
Keywords: Physical therapy modalities,
Electric stimulation therapy
Indirect calorimetry
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2019-01-25
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study will investigate the effects of neuromuscular electrical stimulation (NMES) in critically ill patients. The objective of this study will be investigate the effects of neuromuscular electrical stimulation (NMES) in critically ill patients.

Detailed description: The study will investigate the effects of neuromuscular electrical stimulation (NMES) in critically ill patients. It will be a randomised crossover clinical trial. Thirty-one patients will enrolled. Patients will be selected, randomly, to the intervention Protocol (decubitus position with the limbs raised and NMES) and control (decubitus position with the limbs raised without NMES).The patients will be allocated in Group 1 (intervention and control) or group 2 (control and intervention) with a wash-out period of 4 to 6 hours between them.

The main outcome will be metabolic data. Linear mixed model will be used for analysis of dependent variables and estimated values of the mean of the differences of each effect.

The results of this study will allow better understanding of the metabolic effects of NMES in patients critically ill.

Eligibility criteria: Inclusion Criteria:

* All patients that will be admitted to the intensive care unit
* Hemodynamic stability
* Mechanical ventilation.

Exclusion Criteria:

1. In general:

   * a. Pregnant women
   * b. Brain death
   * c. Neuromuscular diseases
   * d. Use of pre-existing neuromuscular blocker in the last 24 hours, prior to the study protocol.
2. Contraindications for the use of NMES:

   * a. Fractures
   * b. Burns
   * c. Skin lesions
   * d. Systemic vascular impairment diseases such as systemic lupus erythematosus, thromboembolic disease, deep vein thrombosis (which was not therapeutically anticoagulated for a time greater than 36 hours)
   * e. Lower limb amputations
   * f. Cardiac pacemaker,
   * g. Thrombocytopenia less than 20,000/mm3
   * h. BMI greater than 35 kg/m2
   * i. Important lower extremity oedema
   * j. Agitation and/or signs of pain during the electrical stimulation.
3. Contraindications to begin or continue NMES procedure:

   * a. Mean arterial blood pressure less than 65 mmHg
   * b. Use of vasopressor \>50% of themaximum dose (dopamine \>12.5 μg/kg per minute; vasopressin \>0.02U/min and norepinephrine \>1 μg/kg per minute),
   * c. Heart rate \<50 or \>140bpm
   * d. Arrhythmias with hemodynamic consequences
   * e. Myocardial ischemia,
   * f. Temperature \<34 or \>39oC
   * g. Intracranial pressure \>20 cmH2O
   * h. Decrease in 10% of SpO2 baseline value or \<88% for more than one minute.

Primary outcomes:
measure: Change of Oxygen consumption (VO2),from baseline and interventions.
timeFrame: VO2 will be taken during the each intervention, it will be taken only the first day
Secondary outcomes:
measure: Change of Carbon dioxide production (VCO2) from baseline and interventions.
timeFrame: VCO2 will be taken during the each intervention, it will be taken only the first day
Other outcomes:
measure: Change of Resting energy expenditure (REE) from baseline and interventions.
timeFrame: REE will be taken during the each intervention, it will be taken only the first day
Locations:
city: Ribeirão Preto
country: Brazil
facility: Clinics Hospital
state: São Paulo
Study officials:
affiliation: Ribeirao Preto Medicine School-University of São Paulo
name: Ada C Gastaldi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lago AF, Basile-Filho A, de Oliveira AS, de Souza HCD, Dos Santos DO, Gastaldi AC. Effects of physical therapy with neuromuscular electrical stimulation in acute and late septic shock patients: A randomised crossover clinical trial. PLoS One. 2022 Feb 17;17(2):e0264068. doi: 10.1371/journal.pone.0264068. eCollection 2022.