Safety and Acceptability of Patient -administered Sedation During Mechanical Ventilation


The primary objective of the study is to assess the efficacy of patient controlled sedation (Self-management of sedative therapy) using dexmedetomidine to reduce anxiety, delirium incidence and duration of mechanical ventilation compared to usual sedation practices in mechanically ventilated subjects.

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18 Years to old
Inclusion Criteria:
Subject is acutely mechanically ventilated during the current hospitalization. Subject is currently receiving a continuous intravenous infusion of a sedative/opioid medication(s) or has received at least one intravenous bolus dose of a sedative/opioid medication in the previous 24 hours (fentanyl, hydromorphone, ketamine, morphine, midazolam, diazepam, lorazepam, propofol, haloperidol, dexmedetomidine). Subject must pass pre-Patient-Controlled Sedation (PCS) screening test and be assessed Richmond Agitation-Sedation Scale (RASS) -2 to +1 Subject Age ≥ 18 years Subject or their proxy is capable of providing informed consent
Exclusion Criteria:
Aggressive ventilatory support or prone ventilation. Hypotension (systolic blood pressure < 85 mmHg) requiring a vasopressor at a dose greater than norepinephrine or epinephrine 0.15 mcg/kg/min or vasopressin > 2.4 units per hour. Subjects will be excluded if they require more than one continuous infusion of a catecholamine vasopressor medication simultaneously. Subjects will be excluded if the vasopressor dose was higher than norepinephrine or epinephrine 0.15 mcg/kg/min, vasopressin > 2.4 units per hour, phenylephrine >3 mcg/kg/min, dopamine >10 mcg/kg/min or dobutamine at any dose in the prior 6 hours. If dopamine is being used to increase heart rate, rather than as a vasopressor for hypotension, subject will be excluded. Second or third degree heart block or bradycardia (heart rate < 50 beats/min). Paralysis or other condition preventing the use of push button device Positive pregnancy test or lactation Acute hepatitis or liver failure (direct bilirubin >5 mg/dL) Acute stroke or uncontrolled seizures. Acute myocardial infarction within 48 hours prior to enrollment. Severe cognition or communication problems (such as coma, deafness without signing literacy, physician-documented dementia) Assessed RASS -3, -4, -5 or RASS +2,+3, +4 Chronic ventilator support in place of residence prior to current hospitalization. Imminent extubation from mechanical ventilator support.

Drug: Dexmedetomidine

Critical Illness, Anxiety, Respiratory Failure

Craig Weinert -
Craig Weinert
Phase 2/Phase 3
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