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.
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.
Critical Illness, Anxiety, Respiratory Failure
Craig Weinert - email@example.com
Phase 2/Phase 3
1605M88241See this study on ClinicalTrials.gov