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 @ 5:01 AM
Ignite Modification Date:
2025-12-25 @ 5:01 AM
NCT ID:
NCT06936618
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years
* Diagnosed with acute hypoxemic respiratory failure within 48 hours
* Expected to require invasive mechanical ventilation ≥ 48 hours
* On mechanical ventilation within 24 hours
* Deep sedation and neuromuscular blockade
Exclusion Criteria:
* Pregnancy
* Body mass index (BMI) \> 40 kg/m2
* Contraindications to using electrical impedance tomography, including
* Presence of a pacemaker or automatic implantable cardioverter-defibrillator (AICD)
* Inability to place the belt due to presence of surgical wounds dressing, thoracic or spinal cord trauma, recent thoracic surgery, etc.
* High risk for PEEP titration
* Hemodynamic instability defined as mean arterial pressure \< 65 mmHg despite optimization of fluid status and/or use of vasopressors
* Unstable cardiac arrhythmias
* Presence of lung bullae greater than 2 cm in diameter, identified on chest X-ray
* Presence of pneumothorax or pneumomediastinum
* Right-sided heart failure or severe pulmonary hypertension
* Neurologic conditions associated with a risk of intracranial hypertension
* Use of extracorporeal membrane oxygenation (ECMO)
* Severe chronic respiratory disease, defined as follows: requiring home oxygen therapy, or previous lung function showing (FEV1 less than 20 ml/kg PBW, or FEV1/FVC less than 50% predicted value), or chronic hypercapnia (PaCO2 greater than 45 mmHg) and/or chronic hypoxemia (PaO2 less than 55 mmHg) on FIO2 = 0.21, or radiographic x-ray evidence of any chronic over-inflation or chronic interstitial infiltration, or chronic restrictive, obstructive, neuromuscular, chest wall or pulmonary vascular disease resulting in severe exercise restriction (unable to climb stairs or perform household duties, secondary polycythemia, severe pulmonary hypertension with mean pulmonary arterial pressure greater than 40 mmHg)
* Decision to withhold life-sustaining treatment or palliative care.
* Moribund status with an expected survival of less than 24 hours.
* Refusal to provide informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06936618
Study Brief:
Protocol Section:
NCT06936618