At a glance
ClinicalIndex Comparison Record- ✓Currently on mechanical ventilation
- ✓Recent sedative or opioid use (continuous infusion or bolus in prior 24 hours)
- ✓Pass pre-PCS screening test
- ✓RASS score between -2 and +1
- ✕Aggressive ventilatory support or prone ventilation
- ✕Severe hypotension requiring high-dose vasopressors (norepinephrine/epinephrine >0.15 mcg/kg/min, vasopressin >2.4 units/hr, or multiple catecholamine infusions)
- ✕Heart block (2nd or 3rd degree) or severe bradycardia (HR <50 bpm)
- ✕Unable to use push-button device (paralysis or other condition)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Efficacy of Self-management of Sedative Therapy by Ventilated ICU Patients
In Brief
A Phase 3 clinical trial evaluating Dexmedetomidine for Critical Illness and 2 related conditions. Completed, enrolled 161 participants across 2 sites.
Detailed 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.
Study Details
Timeline
Interventions
Patient will receive a maintenance intravenous infusion of medication (Dexmedetomidine) and have access to self-controlled sedation medication (Dexmedetomidine) for anxiety.