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:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-26 @ 10:58 AM
NCT ID:
NCT06454006
Eligibility Criteria:
Inclusion Criteria:
* Legally authorized representative signed informed consent;
* Male or female aged 21 years or older;
* On mechanical ventilation through orotracheal intubation for no more than 72 hours prior to study enrollment or pending mechanical ventilation through orotracheal intubation;
* Predicted to remain on mechanical ventilation for at least 48 hours (≥48 hours) from the time of study enrollment
Exclusion Criteria:
* Mechanical ventilation initiated longer than 72 hours prior to anticipated enrollment;
* Body Mass Index (BMI) \> 40 kg/m²;
* Fever of 100.4°C or higher;
* Situated in the prone position for 24 hours or longer during mechanical ventilation;
* Prognosis of mortality within 72 hours, per the patient's physician;
* Hypersensitivity to light;
* Use of non-invasive ventilation, Continuous Positive Airway Pressure (CPAP) and/or Bilevel Positive Airway Pressure (BiPAP) device for ≥ 50% of the time over the preceding 6 months;
* Tracheostomy;
* Any one or more of the following present on both sides of the neck (bilaterally) at the intended treatment site(s): internal jugular (IJ) venous cannulation; incisions, significant bruising; burn(s); notable skin irritation/rash, or other skin condition that may place the subject at risk from harm from the device treatment;
* Fracture, external or internal hemorrhage, or at risk of hemorrhage following acute trauma or fracture, or known or potential acute occult bleeding (e.g., gastric ulcer, intestine) in the intended treatment areas;
* Metallic device implants or body penetrating metallic devices in the upper body/neck area whose location may interfere with the study device treatment administration. E.g., extracorporeal membrane oxygenation (ECMO) cannula;
* Non-removable electrical/electronic device in the upper body/neck area that may interfere with the study device treatment administration, e.g., -implanted pacemaker or cardiac defibrillator;
* Cardiogenic or septic shock with ongoing severe hemodynamic instability (according to the American College of Chest Physicians definition (that cannot be stabilized within the 48 hours enrollment period);
* Conditions that may limit ultrasonographic assessment of diaphragmatic thickness, e.g., occluding chest drain, pleural effusion, pulmonary consolidation of the lower lobe(s);
* Current cancer of any type;
* Pregnancy;
* Any comorbidity, co-existing condition or illness, or other factor that in the opinion of the study investigator may render the subject unsuitable for participation in the study;
* Admission to the ICU within the last 12 months due to respiratory distress/failure;
* Two or more admissions to the ICU within the prior 12 months for any reason;
* Current participation in another clinical study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT06454006
Study Brief:
Protocol Section:
NCT06454006