Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2025-12-25 @ 4:29 AM
NCT ID:
NCT05450120
Eligibility Criteria:
Inclusion Criteria:
Subjects admitted in ICU for \>72hs, undergoing orotracheal intubation and on mechanical ventilation for \>48hs, with a diagnosis of Acute Respiratory Distress Syndrome (ARDS) according to Berlin definition secondary to COVID-19, with shock or organ failure, according to the Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (7th Interim Edition) Guideline, and clinical stability:
* mean arterial pressure \< 60 mmHg;
* heart rate \>60 and \<120 beats/minute;
* respiratory rate \<30 breaths/minute;
* oxygen saturation ≥ 92%;
* fraction of inspired oxygen (FiO2) ≤0.6;
* absence of vasopressor dose increase
* absence of dysrhythmia (except for chronic atrial fibrillation);
* controlled sepsis;
* hemoglobin (Hb) \> 8g m/d, plaquettes \>20.000, Glucemia \>70 e \<180;
* without NMBs
Exclusion Criteria:
* Patients with movement resistance
* Walking without assistance before the ICU (except using a cane)
* Cognitive impairment before acute illness
* Signs of intracranial hypertension, neuromuscular disease (myasthenia gravis, amyotrophic lateral sclerosis, Guillain-Barré) and stroke; hip fracture, unstable cervical spine, or pathological fracture
* Prior hospitalization (30 days before ICU)
* Readmission to the ICU, within the current hospitalization
* Presence of an implanted cardiac pacemaker or defibrillator, pregnancy, acute myocardial infarction and, for the experimental group (EG), against indications for NMES (deep vein thrombosis, skin lesions, rhabdomyolysis).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05450120
Study Brief:
Protocol Section:
NCT05450120