Self-management of Sedative Therapy by Ventilated Patients

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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-PCS screening test and be assessed RASS -2 to+1.
Subject age ≥ 18 years old.
Subject or their proxy is capable of providing informed consent

Exclusion Criteria:

Aggressive ventilatory support or prone ventilation.
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.
Second or third degree heart block or bradycardia (heart rate < 50 beats/min).
Paralysis or other condition preventing the use of push button device.
Positive pregnancy test or lactation.
Acute hepatitis or acute liver failure (direct bilirubin > 5mg/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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Rochester, Minn. Mayo Clinic principal investigator Linda Chlan, Ph.D., R.N.	Closed for enrollment	Contact information: Pamela Peterson R.N. (507)255-0068 Peterson.Pamela@mayo.edu

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Linda Chlan, Ph.D., R.N.

Closed for enrollment

Contact information:

Pamela Peterson R.N.

(507)255-0068

Peterson.Pamela@mayo.edu

More information

Publications

Administration of sedative and opioid medications to patients receiving mechanical ventilatory support in the intensive care unit is a common clinical practice. Read More on PubMed
Although potent sedative and opioid drugs are some of the most commonly used medications to manage pain, anxiety, and discomfort in critically ill patients, conducting clinical trials where sedative and opioid medications are outcome variables within a longitudinal research design can be a methodological challenge. Read More on PubMed

Clinical Trials