Self-management of Sedative Therapy by Ventilated Patients

The overall objective of this study is to demonstrate efficacy for conducting a future,
pragmatic effectiveness trial to test whether self-management of sedative therapy (SMST) is
superior to nurse-administered sedative therapy in day-to-day intensive care unit (ICU)
practice. This efficacy trial is powered for the investigators primary, clinically relevant
endpoints (anxiety, duration of mechanical ventilation, and delirium presence), and examines
patient outcomes adversely affected by sedative administration practices, such as prolonged
ICU stays, altered mental status, and diminished post-ICU quality of life. This randomized
clinical trial with a total of 190 mechanically ventilated patients enrolled and maintained
on protocol will address the following Specific Aims.

The primary aim is to determine the efficacy of SMST compared to nurse-administered sedative
therapy on anxiety, duration of mechanical ventilation, and presence of delirium in
mechanically ventilated patients (MVPs).

The secondary aim is to compare level of arousal and sedative exposure in mechanically
ventilated patients (MVPs) randomized to SMST to those MVPs receiving nurse-administered
sedative therapy. The investigators hypothesize that SMST patients will be easily arousable,
more alert, and exposed to less sedation than those who receive nurse-administered sedative
therapy.

An exploratory aim is to compare post-ICU outcomes (physical/functional status, psychological
well-being, and health-related quality of life) between MVPs randomized to SMST and those
receiving nurse-administered sedative therapy.

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 such as positive end expiratory pressure > 15 cm of
water 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. General anesthesia within 12 hours prior to enrollment.

8. Acute stroke or uncontrolled seizures.

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

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

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

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

13. Imminent extubation from mechanical ventilator support.