Self-management of Sedative Therapy by Ventilated Patients

• Status: Recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); University of Minnesota; University of Minnesota, MN
• Treatments: Dexmedetomidine; Hypnotics and Sedatives

Criteria

Inclusion Criteria:

1. Subject is acutely mechanically ventilated during the current hospitalization.

2. 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).

3. Subject must pass pre-Patient-Controlled Sedation (PCS) screening test and be assessed Richmond Agitation-Sedation Scale (RASS) -2 to +1

4. Subject Age ≥ 18 years

5. Subject or their proxy is capable of providing informed consent

Exclusion Criteria:

1. Aggressive ventilatory support or prone ventilation.

2. 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.

3. Second or third degree heart block or bradycardia (heart rate < 50 beats/min).

4. Paralysis or other condition preventing the use of push button device

5. Positive pregnancy test or lactation

6. Acute hepatitis or liver failure (direct bilirubin >5 mg/dL)

7. Acute stroke or uncontrolled seizures.

8. Acute myocardial infarction within 48 hours prior to enrollment.

9. Severe cognition or communication problems (such as coma, deafness without signing literacy, physician-documented dementia)

10. Assessed RASS -3, -4, -5 or RASS +2,+3, +4

11. Chronic ventilator support in place of residence prior to current hospitalization.

12. Imminent extubation from mechanical ventilator support.