Patients take control: Self-Sedation may ease anxiety in the ICU
NCT ID NCT02819141
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether critically ill patients on breathing machines could safely manage their own sedation using a button-controlled device. 161 adults in the ICU were randomly assigned to either self-manage their sedation or have it managed by a nurse. The goal was to see if self-management reduced anxiety, time on the ventilator, and confusion. The approach aims to give patients more control over their comfort during a stressful hospital stay.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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161 people
The number who actually took part.
- Started
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Nov 2016
- Finished
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Dec 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
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School of Medicine, University of Minnesota
Minneapolis, Minnesota, 55455, United States
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