Respiratory Insufficiency Clinical Trial
— TOESOfficial title:
Impact of Totally Transdermal Sedation in the Weaning From Remifentanil Infusion Among Critically Ill Patients Undergoing Mechanical Ventilation: a Pilot Randomized-controlled Study (The TOES Trial)
Verified date | January 2024 |
Source | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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)
Status | Completed |
Enrollment | 24 |
Est. completion date | April 6, 2024 |
Est. primary completion date | April 6, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Italy | Fondazione Policlinico Universitario A. Gemelli IRCCS | Roma |
Lead Sponsor | Collaborator |
---|---|
Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
Italy,
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* Note: There are 21 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison of the work of breathing (WOB) of the patients randomized to receive transdermal fentanyl vs. remifentanil alone. | To demonstrate that the area under the curve (AUC) of the work of breathing per minute (cmH20*sec/min) (assessed at 1, 6, 12, 24 hours for the first day after randomization, and every 24 hours for the following days) in the intervention group is not higher than the control group. | starts with the randomization and ends 72 hours after randomization | |
Primary | Comparison of the work of breathing per breath of the patients randomized to receive transdermal fentanyl vs. remifentanil alone. | cmH20*sec/min | starts with the randomization and ends 72 hours after randomization | |
Primary | Comparison of the inspiratory effort of the patients randomized to receive transdermal fentanyl vs. remifentanil alone. | cmH20 | starts with the randomization and ends 72 hours after randomization | |
Primary | Comparison of the delta electrical activity of the diaphragm (EAdi) of the patients randomized to receive transdermal fentanyl vs. remifentanil alone. | microvolt (mcv) | starts with the randomization and ends 72 hours after randomization | |
Primary | Comparison of the plateau pressures of the patients randomized to receive transdermal fentanyl vs. remifentanil alone. | cmH20 | starts with the randomization and ends 72 hours after randomization | |
Primary | Comparison of driving pressures of the patients randomized to receive transdermal fentanyl vs. remifentanil alone. | cmH20 | starts with the randomization and ends 72 hours after randomization | |
Primary | Comparison of transpulmonary driving pressures of the patients randomized to receive transdermal fentanyl vs. remifentanil alone. | cmH20 | starts with the randomization and ends 72 hours after randomization | |
Primary | Comparison of the pulmonary compliance of the patients randomized to receive transdermal fentanyl vs. remifentanil alone. | ml/cmH20 | starts with the randomization and ends 72 hours after randomization | |
Primary | Comparison of P0.1 of the patients randomized to receive transdermal fentanyl vs. remifentanil alone. | cmH20 | starts with the randomization and ends 72 hours after randomization | |
Primary | Comparison of P/F ratios of the patients randomized to receive transdermal fentanyl vs. remifentanil alone. | The P/F ratio equals the arterial PaO2 (Arterial Oxygen Partial Pressure) (mmHg) divided by the FIO2 (the fraction of inspired oxygen expressed as a decimal) | starts with the randomization and ends 72 hours after randomization | |
Secondary | Comparison of respiratory rates of the patients randomized to receive transdermal fentanyl vs. remifentanil alone. | breaths per minute | starts with the randomization and ends 72 hours after randomization | |
Secondary | Comparison of tidal volumes of the patients randomized to receive transdermal fentanyl vs. remifentanil alone. | milliliters | starts with the randomization and ends 72 hours after randomization | |
Secondary | Comparison of arterial blood pressure of the patients randomized to receive transdermal fentanyl vs. remifentanil alone. | mmHg | starts with the randomization and ends 72 hours after randomization | |
Secondary | Comparison of heart rates of the patients randomized to receive transdermal fentanyl vs. remifentanil alone. | bpm | starts with the randomization and ends 72 hours after randomization | |
Secondary | Global duration of mechanical ventilation among the two groups. | Days | starts with the randomization and ends with the discharge from the intensive care unit. | |
Secondary | Global duration of intravenous remifentanil infusion among the two groups. | Hours | starts with the randomization and ends with the discharge from the intensive care unit. | |
Secondary | Length of stay in hospital among the two groups. | Days | starts with the randomization and ends with the discharge from the Hospital. | |
Secondary | Length of stay in ICU among the two groups. | Days | starts with the randomization and ends with the discharge from the intensive care unit. |
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