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 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT02801994
Eligibility Criteria:
Inclusion Criteria:
Patients will be included as soon as the meet the following criteria.
* Intubation and mechanical ventilation for a respiratory cause with severe hypoxemia defined as a PaO2 to FiO2 ratio \<300 recorded at least once during the present ICU stay.
* PSV ventilation for \> 6 hours.
* Severe patient-ventilator disharmony defined by either
* a dyspnea ≥ 4 on a visual analogic scale (VAS) from 0 to 10 with respiratory rate ≥ 24 /minute and a drawing of neck muscles,
* or by an asynchrony index (IA) ≥ 10%, defined as = number of asynchrony events/total respiratory rate (ventilator cycles +wasted efforts) × 100
* No improvement of disharmony despite an optimization of ventilator setting defined as follows.
* No improvement of dyspnea or double triggering despite an increase of the level of pressure support that should not generate a tidal volume \> 10 ml/kg
* No improvement of ineffective efforts despite a decrease of the level of pressure support or generation of a dyspnea (defined as VAS\>4) in response of the decrease of the level of pressure support.
* Decision of the physician in charge of the patient to switch mechanical ventilation from PSV mode to PAV.
* Remaining duration of mechanical ventilation estimated ≥ 24 hours.
* Patient able to communicate (Richmond Agitation and Sedation Scale between -1 and +1).
Exclusion Criteria:
* Exclusion criteria will be as follows.
* Severe hypoxemia defined as a PaO2 to FiO2 ratio \<150 mmHg.
* Delirium according to the CAM-ICU (1)
* Hemodynamic instability defined by the need for intravenous fluids or catecholamine during the previous 24 hours.
* Age \<18 years; pregnant woman.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02801994
Study Brief:
Protocol Section:
NCT02801994