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 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 12:35 AM
NCT ID:
NCT04204967
Eligibility Criteria:
Inclusion Criteria:
* Age \> 18 yo;
* Negative pregnancy test prior to inclusion in the study;
* The informed consent form needs to be signed and dated by the patient or a relative/legal guardian before of any procedure related to the study; if the patient is initially unable to sign the informed consent form, but later regains the ability to sign it, a new informed consent form will be given to the patient and must be signed and dated;
* Mechanically ventilated in Pressure Support Ventilation, according to the decision to the attending physician;
* A patient with prolonged weaning from the mechanical ventilator will be considered eligible. Prolonged weaning is defined as weaning that is still not terminated 7 days after the first separation attempt from the ventilator (by success or death).
* Analgesia provided by continuous infusion of remifentanil lasting five days or more and an intolerance to a dose reduction of 0.025 mcg/kg/min defined as the presence of at least one of the following criteria: RASS ≥ 2, a respiratory rate ≥ 35 breaths/minute, a PaCO2 \< 30 mmHg, a heart rate \> 120 bpm, a systolic blood pressure value \> 160 mmHg or an increase of Visual Analogue Scale for pain assessment of ≥ 2 points.
Exclusion Criteria:
* Hypersensitivity to the active substance or any of the excipients;
* Hepatic or renal impairment;
* Fever (body temperature ≥ 38 °C) or septic shock, hypothermia (body temperature \< 35 °C) or presence of active surface cooling systems;
* Hypercapnic patients with a PaCO2 \> 45 mmHg;
* Current enrollment or plan to enroll in any interventional clinical study in which an investigational treatment or approved therapy for investigational use is administered within 30 days or 5 half-lives of the agent, prior to the baseline visit;
* Hypoxemic respiratory failure (P/F \< 200 mmHg);
* Delirium state defined as RASS ≥ 3 and CAM-ICU positive;
* Hemodynamic instability requiring high doses of inotropes or vasopressors;
* Any condition that may contraindicate the use of remifentanil or transdermal fentanyl;
* Patients with a BMI ≥ 35;
* Patient admitted for postoperative monitoring after elective surgery;
* EAdi catheter contraindicated.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04204967
Study Brief:
Protocol Section:
NCT04204967