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Patients take control: Self-Sedation may ease anxiety in the ICU

NCT ID NCT02819141

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

161 people

The number who actually took part.

Started

Nov 2016

Finished

Dec 2024

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905, United States

  • School of Medicine, University of Minnesota

    Minneapolis, Minnesota, 55455, United States

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Other studies related to the condition(s) this trial covers.