Phase 3
N=161
Self-management of Sedative Therapy by Ventilated Patients
Critical Illness · Anxiety · Respiratory Failure
Bottom Line
View on ClinicalTrials.gov: NCT02819141 ↗Enrolled (actual)
161
Serious AEs
10.6%
Results posted
Oct 2025
Primary outcome: Primary: Anxiety Rating Using the 100mm Vertical Visual Analog Scale — 44.4; 43.4; 40.5; 33.1 score on a scale — p=0.30
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Dexmedetomidine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Anxiety Rating Using the 100mm Vertical Visual Analog Scale |
44.4; 43.4; 40.5; 33.1; 45.1; 40.9 | 0.30 |
| PRIMARY Duration of Mechanical Ventilatory Support After Study Enrollment |
68.7; 50.3 | 0.02 sig |
| PRIMARY Incidence of Delirium Using the Confusion Assessment Method-ICU (CAM-ICU) |
15; 7; 14; 10; 9; 5 | 0.97 |
| SECONDARY Comparison of Level of Arousal and Agitation Using the Richmond Agitation-Sedation Scale (RASS) |
65; 68; 12; 5; 42; 32 | 0.39 |
| SECONDARY Comparison of Daily Sedation Intensity Each ICU Study Day Using Electronic Health Record Medication Data of Any of Nine Intravenous Sedative Medications Administered to Patients. |
10.2; 9.1; 17.3; 16.6; 17.4; 20.7 | 0.37 |
| SECONDARY Comparison of Daily Sedation Frequency Using Electronic Health Record Medication Data of Any of Nine Intravenous Sedative Medications Administered to Patients. |
13.9; 13.5; 24.6; 22.9; 24.3; 25.0 | — |
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.
Eligibility Criteria
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 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 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.
Data sourced from ClinicalTrials.gov (NCT02819141). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.