Self-management of Sedative Therapy by Ventilated Patients (NCT02819141) | Clinical Trial Compass
CompletedPhase 2/3
Self-management of Sedative Therapy by Ventilated Patients
United States161 participantsStarted 2016-11
Plain-language summary
The purpose of this randomized clinical trial is to test the efficacy of dexmedetomidine for the self-management of sedative therapy (SMST) in a sample of critically ill patients receiving mechanical ventilator support. The investigators hypothesis is that self-management of sedative therapy by mechanically ventilated patients in the intensive care unit (ICU), tailored to their individual needs will be more efficacious than nurse-administered sedative therapy in reducing anxiety, which may reduce duration of mechanical ventilator support and occurrence of delirium.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Anxiety Rating Using the 100mm Vertical Visual Analog Scale
Timeframe: 7 days
2
Duration of Mechanical Ventilatory Support After Study Enrollment
Timeframe: 7 days
3
Incidence of Delirium Using the Confusion Assessment Method-ICU (CAM-ICU)