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 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 12:31 AM
NCT ID:
NCT03512067
Eligibility Criteria:
Inclusion Criteria:
* Adult (at least 18 years of age), mechanically ventilated via endotracheal tube, of either sex
* Capable of triggering the ventilator
* Subject receiving pressure support ventilation (or assist/control pressure-limited mechanical ventilation) with less than or equal to 15 cm H2O inspiratory pressure, or, if on volume-limited A/C, when switched to pressure-limited A/C with the inspiratory pressure set to match the tidal volume on volume-limited A/C, the resultant inspiratory pressure is less than or equal to 15 cm H2O.
* Stable on the above-mentioned ventilatory support for at least 8 hours.
* Arterial line in place for obtaining arterial blood gases
Exclusion Criteria:
* Requiring high inspiratory oxygen concentration (\> 50%).
* Requiring high ventilatory driving pressure (\> 15 cm H20 on pressure-support)
* High spinal cord injury
* Immunosuppressed, \< 2 months after receiving chemotherapy or radiation therapy.
* Neuromuscular/ neurological disease of a progressive nature resulting in chronic ventilator dependence.
* High risk of mortality within 3 months (terminal stage of their disease).
* Unable to spontaneously trigger the ventilator for any reason.
* Not considered a candidate for weaning from ventilatory support
* Consented for another interventional study.
* Requiring deep sedation and analgesia \[Richmond Agitation Sedation Scale -3 to -5 (RASS)\]
* Hemodynamically unstable patients as defined by those requiring norepinephrine at a dose greater than 5 mcg/min or neosynephrine \> 100 mcg/min or those with a mean arterial blood pressure \< 55 or \> 120 mmHg or those with a heart rate \< 50 or \> 140 bpm.
* Respiratory rate \> 30 breaths/min
* Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03512067
Study Brief:
Protocol Section:
NCT03512067