Totally Transdermal Sedation in the Weaning From Remifentanil Infusion

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The choice of the sedation protocol has a massive impact on the duration of mechanical ventilation and the timing of extubation. Many sedation protocols are described in the literature. The investigators aim to assess if a transdermal fentanyl-based sedation protocol can have an impact on the global Work of Breathing (WOB)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Treatments: Fentanyl; Remifentanil

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.