Clinical trial NCT02819141: Self-management of Sedative Therapy by Ventilated Patients
Official title: Efficacy of Self-management of Sedative Therapy by Ventilated ICU Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Critical Illness
Anxiety
Respiratory Failure
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: University of Minnesota
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2016-06-30
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Exploratory aims are to compare post-ICU outcomes (physical/functional status, psychological well-being, and health-related quality of life) and recall of ICU experiences between MVPs randomized to SMST and those receiving nurse-administered sedative therapy.

Eligibility 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.

Primary outcomes:
measure: Changes in anxiety using the 100mm vertical visual analog scale
timeFrame: 7 days
measure: Changes in duration of days receiving mechanical ventilation after study enrollment
timeFrame: up to 6 months
measure: Changes in delirium using the CAM-ICU tool
timeFrame: 7 days
Secondary outcomes:
measure: Comparison of level of arousal and alertness using the Richmond Agitation-Sedation Scale
timeFrame: 7 days
measure: Comparison of sedative exposure (sedation frequency + sedation intensity) using electronic health record data of intravenous sedative medications.
timeFrame: each 24-hour period, up to 7 days
Other outcomes:
measure: Comparison of post-ICU physical status using the Katz Activities of Daily Living scale
timeFrame: 3 and 6 months after ICU discharge over the telephone
measure: Comparison of post-ICU functional status using the Functional Activities Questionnaire
timeFrame: 3 and 6 months after ICU discharge over the telephone
measure: Comparison of post-ICU psychological well-being status using the Patient Health Questionnaire
timeFrame: 3 and 6 months after ICU discharge over the telephone
measure: Comparison of post-ICU psychological well-being status using the Posttraumatic Stress Disorder Checklist Event Specific scale
timeFrame: 3 and 6 months after ICU discharge over the telephone
measure: Comparison of post-intensive care unit health-related quality of life using the Short-Form 36
timeFrame: 3 and 6 months after ICU discharge over the telephone
measure: Comparison of immediate post-extubation recollections of ICU using the Intensive Care Experience questionnaire
timeFrame: 24 to 48 hours after extubation, 3 and 6 months after ICU discharge over the telephone
measure: Relationships among cognitive experiences using the Confusion Assessment Method-ICU and awareness using the Richmond Agitation-Sedation Scale with mechanical ventilation complications of device disruption or self-extubation
timeFrame: 24 to 48 hours after extubation
Locations:
city: Minneapolis
country: United States
facility: School of Medicine, University of Minnesota
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Linda L Chlan, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tracy MF, Chlan L, Savik K, Skaar DJ, Weinert C. A Novel Research Method for Determining Sedative Exposure in Critically Ill Patients. Nurs Res. 2019 Jan/Feb;68(1):73-79. doi: 10.1097/NNR.0000000000000322.
citation: Chlan LL, Weinert CR, Tracy MF, Skaar DJ, Gajic O, Ask J, Mandrekar J. Study protocol to test the efficacy of self-administration of dexmedetomidine sedative therapy on anxiety, delirium, and ventilator days in critically ill mechanically ventilated patients: an open-label randomized clinical trial. Trials. 2022 May 16;23(1):406. doi: 10.1186/s13063-022-06391-w.