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:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2025-12-24 @ 4:55 PM
NCT ID:
NCT07188350
Eligibility Criteria:
Inclusion Criteria:
* Patients will be eligible if they are 18 years or older, are under invasive mechanical ventilation (IMV), and are expected to require IMV for more than 48 hours.
Exclusion Criteria:
* Body mass index (BMI) greater than or equal to 35 kg/m²;
* Length of ICU stay longer than 7 ICU-free days or more than 3 continuous days of invasive mechanical ventilation (IMV) before enrollment;
* Known intracranial process (e.g., stroke, intracranial hypertension);
* Neuromuscular disease (e.g., Guillain-Barré syndrome, myasthenia gravis) at ICU admission;
* Inability to speak Portuguese or pre-existing cognitive impairment prior to ICU admission;
* Any condition that prevents neuromuscular electrical stimulation (NMES) treatment or assessment of the primary outcome in both legs (e.g., skin lesions, fractures, or amputation);
* Inability to transfer independently from bed to chair before ICU admission;
* Cardiac arrest as the cause of ICU admission or cardiac arrest before screening;
* Deep vein thrombosis (DVT) or pulmonary embolism (PE) treated for less than 48 hours;
* Pregnant patients;
* Known or suspected malignancy in the legs;
* Any care limitation including a do-not-resuscitate order.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07188350
Study Brief:
Protocol Section:
NCT07188350