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Completed

NCT Number: NCT02819141

Self-management of Sedative Therapy by Ventilated Patients

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.

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Key information

Conditions

Critical Illness Anxiety Anxiety Disorders Disease Attributes Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Failure Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

School of Medicine, University of Minnesota, Minneapolis, Minnesota, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for 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-Patient-Controlled Sedation (PCS) screening test and be assessed Richmond Agitation-Sedation Scale (RASS) -2 to +1
  • Subject Age ≥ 18 years
  • 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 liver failure (direct bilirubin >5 mg/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.

Treatment and study plan

Dexmedetomidine

Drug

Patient will receive a maintenance intravenous infusion of medication (Dexmedetomidine) and have access to self-controlled sedation medication (Dexmedetomidine) for anxiety.

Other names: Precedex

Primary outcomes

  1. Anxiety Rating Using the 100mm Vertical Visual Analog Scale

    Time frame: 7 days

    Vertical visual analog scale will be used to measure level of state anxiety from 0/zero (no anxiety) to 100 (most anxiety ever). Higher scores mean more anxiety.

  2. Duration of Mechanical Ventilatory Support After Study Enrollment

    Time frame: 7 days

    Duration of time (hours) patients received mechanical ventilatory support after randomization to either Control or dexmedetomidine self-management of sedative therapy to extubation.

  3. Incidence of Delirium Using the Confusion Assessment Method-ICU (CAM-ICU)

    Time frame: 7 days

    Confusion Assessment Method-ICU (CAM-ICU) used to assess for the presence (CAM-ICU+) or absence (CAM-ICU-) of delirium at each assessment.

Secondary outcomes

  1. Comparison of Level of Arousal and Agitation Using the Richmond Agitation-Sedation Scale (RASS)

    Time frame: 7 days

    The Richmond Agitation-Sedation Scale (RASS) was used to assess the level of alertness and agitation in enrolled patients. Scores range from -5 to +4. RASS 0/zero indicates alert and calm patient. Negative scores (-1 to -5) indicate increasing level of sedation with -5 indicating unarousable. Positive scores indicate increasing agitation (+1 to +4) with +4 indicating a combative patient. For enrolled study patients, RASS score -2 (light sedation) to +1 (restless) was considered in range. We report here the total number of patients assessed as outside the desirable range of RASS score -5 to -3 and +2 to +4 by each ICU study day.

  2. Comparison of Daily Sedation Intensity Each ICU Study Day Using Electronic Health Record Medication Data of Any of Nine Intravenous Sedative Medications Administered to Patients.

    Time frame: Daily Sedation intensity over a 7-day ICU study protocol period

    Sedation intensity combines the number of sedative doses and the dose amount of any of 9 intravenous (IV) sedative medications (lorazepam, midazolam, propofol, morphine, hydromorphone, dexmedetomidine, fentanyl, haloperidol, ketamine) recorded in the electronic health record, summarized over all patients and time periods each day to obtain medians and quartiles. Each of the 9 sedative drugs administered during each 4-hr period is then assigned a ranking: 0 for drug not used, 1 for the bottom quartile, 2 for the second quartile, 3 for the third, and 4 for the fourth. A score is determined by summing for the 24-hr day over the 6, 4-hour blocks to produce a daily Sedation Intensity Score from 0-36, higher score more intense dosing received of sedative medications.

  3. Comparison of Daily Sedation Frequency Using Electronic Health Record Medication Data of Any of Nine Intravenous Sedative Medications Administered to Patients.

    Time frame: Daily Sedation Frequency over a 7-day ICU study protocol period

    Sedation Frequency is the number of individual intravenous (IV) sedative medication(s) doses administered to patients over each 24-hour day of lorazepam, midazolam, propofol, morphine, hydromorphone, dexmedetomidine, fentanyl, haloperidol, ketamine. Sedation frequency ranges from 0-216 with a higher number indicating more frequent receipt of a sedative medication(s).

Other outcomes

  1. Comparison of Post-ICU Physical Status Using the Katz Activities of Daily Living Scale

    Time frame: Independence in activities of daily living at 3 months and 6 months after hospital discharge over the telephone

    Physical status will be assessed by the Katz Activities of Daily Living scale to assess basic physical abilities like bathing, feeding with 6 questions. Higher scores of 6 indicates the individual is independent, whereas a score of 0 indicates the individual is very dependent.

  2. Comparison of Post-ICU Psychological Well-being Status Using the Patient Health Questionnaire-9

    Time frame: 3 and 6 months after ICU discharge over the telephone

    Psychological well-being will be assessed by the Patient Health Questionnaire (PHQ-9) is a 9-item tool that tracks symptoms of major depression. Scores range from 9-36, with higher scores indicating altered psychological well-being.

  3. Comparison of Post-ICU Psychological Well-being Status Using the Posttraumatic Stress Disorder Checklist Event Specific (PCL) Scale

    Time frame: 3 months and 6 months after ICU discharge over the telephone

    Psychological well-being will be assessed with the Posttraumatic Stress Disorder Checklist Event Specific (PCL) to measure symptoms of posttraumatic stress disorder after a stressful life experience of ICU admission. Scores range from 17-85 with higher scores indicating being symptomatic for posttraumatic stress.

  4. Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Physical Function Domain

    Time frame: 3 months after ICU discharge over the telephone Physical Function Domain

    Post-intensive care unit health-related quality of life will be assessed by the Short-Form-36 (SF-36) at 3- and 6-months after hospital discharge. The SF-36 tracks how well an individual feels and how well they are able to do their usual activities in eight health domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. A higher score defines a more favorable health state scored on a 0-100 range for each of the 8 domain scales.

  5. Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Physical Function Domain

    Time frame: 6 months after ICU discharge over the telephone Physical Function Domain

    Post-intensive care unit health-related quality of life will be assessed by the Short-Form-36 at 3- and 6-months after hospital discharge. The SF-36 tracks how well an individual feels and how well they are able to do their usual activities in eight health domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. A higher score defines a more favorable health state scored on a 0-100 range for each of the 8 domain scales.

  6. Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Role Limitations Domain

    Time frame: 3 months after ICU discharge over the telephone Role Limitations Domain due to Physical Health

    Post-intensive care unit health-related quality of life will be assessed by the Short-Form-36 at 3- and 6-months after hospital discharge. The SF-36 tracks how well an individual feels and how well they are able to do their usual activities in eight health domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. A higher score defines a more favorable health state scored on a 0-100 range for each of the 8 domain scales.

  7. Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Role Limitations Domain

    Time frame: 6 months after ICU discharge over the telephone Role Limitations Domain due to Physical Health

    Post-intensive care unit health-related quality of life will be assessed by the Short-Form-36 at 3- and 6-months after hospital discharge. The SF-36 tracks how well an individual feels and how well they are able to do their usual activities in eight health domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. A higher score defines a more favorable health state scored on a 0-100 range for each of the 8 domain scales.

  8. Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Personal or Emotional Health Domain

    Time frame: 3 months after ICU discharge over the telephone Role Limitations due to Personal or Emotional Health

    Post-intensive care unit health-related quality of life will be assessed by the Short-Form-36 at 3- and 6-months after hospital discharge. The SF-36 tracks how well an individual feels and how well they are able to do their usual activities in eight health domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. A higher score defines a more favorable health state scored on a 0-100 range for each of the 8 domain scales.

  9. Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Using Personal or Emotional Health Domain

    Time frame: 6 months after ICU discharge over the telephone Role Limitations due to Personal or Emotional Health

    Post-intensive care unit health-related quality of life will be assessed by the Short-Form-36 at 3- and 6-months after hospital discharge. The SF-36 tracks how well an individual feels and how well they are able to do their usual activities in eight health domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. A higher score defines a more favorable health state scored on a 0-100 range for each of the 8 domain scales.

  10. Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Using the Energy/Fatigue Domain

    Time frame: 3 months after ICU discharge over the telephone Energy/Fatigue Domain

    Post-intensive care unit health-related quality of life will be assessed by the Short-Form-36 at 3- and 6-months after hospital discharge. The SF-36 tracks how well an individual feels and how well they are able to do their usual activities in eight health domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. A higher score defines a more favorable health state scored on a 0-100 range for each of the 8 domain scales.

  11. Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Using the Energy/Fatigue Domain

    Time frame: 6 months after ICU discharge over the telephone Energy/Fatigue

    Post-intensive care unit health-related quality of life will be assessed by the Short-Form-36 at 3- and 6-months after hospital discharge. The SF-36 tracks how well an individual feels and how well they are able to do their usual activities in eight health domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. A higher score defines a more favorable health state scored on a 0-100 range for each of the 8 domain scales.

  12. Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Emotional Well-being Domain

    Time frame: 3 months after ICU discharge over the telephone Emotional Well-being

    Post-intensive care unit health-related quality of life will be assessed by the Short-Form-36 at 3- and 6-months after hospital discharge. The SF-36 tracks how well an individual feels and how well they are able to do their usual activities in eight health domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. A higher score defines a more favorable health state scored on a 0-100 range for each of the 8 domain scales.

  13. Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Emotional Well-being Domain

    Time frame: 6 months after ICU discharge over the telephone Emotional Well-being

    Post-intensive care unit health-related quality of life will be assessed by the Short-Form-36 at 3- and 6-months after hospital discharge. The SF-36 tracks how well an individual feels and how well they are able to do their usual activities in eight health domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. A higher score defines a more favorable health state scored on a 0-100 range for each of the 8 domain scales.

  14. Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Social Functioning Domain

    Time frame: 3 months after ICU discharge over the telephone social functioning

    Post-intensive care unit health-related quality of life will be assessed by the Short-Form-36 at 3- and 6-months after hospital discharge. The SF-36 tracks how well an individual feels and how well they are able to do their usual activities in eight health domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. A higher score defines a more favorable health state scored on a 0-100 range for each of the 8 domain scales.

  15. Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Socia Functioning Domain

    Time frame: 6 months after ICU discharge over the telephone social functioning

    Post-intensive care unit health-related quality of life will be assessed by the Short-Form-36 at 3- and 6-months after hospital discharge. The SF-36 tracks how well an individual feels and how well they are able to do their usual activities in eight health domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. A higher score defines a more favorable health state scored on a 0-100 range for each of the 8 domain scales.

  16. Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Bodily Pain Domain

    Time frame: 3 months after ICU discharge over the telephone bodily pain

    Post-intensive care unit health-related quality of life will be assessed by the Short-Form-36 at 3- and 6-months after hospital discharge. The SF-36 tracks how well an individual feels and how well they are able to do their usual activities in eight health domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. A higher score defines a more favorable health state scored on a 0-100 range for each of the 8 domain scales.

  17. Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Bodily Pain Domain

    Time frame: 6 months after ICU discharge over the telephone bodily pain

    Post-intensive care unit health-related quality of life will be assessed by the Short-Form-36 at 3- and 6-months after hospital discharge. The SF-36 tracks how well an individual feels and how well they are able to do their usual activities in eight health domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. A higher score defines a more favorable health state scored on a 0-100 range for each of the 8 domain scales.

  18. Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 General Health Domain

    Time frame: 3 months after ICU discharge over the telephone general health perceptions

    Post-intensive care unit health-related quality of life will be assessed by the Short-Form-36 at 3- and 6-months after hospital discharge. The SF-36 tracks how well an individual feels and how well they are able to do their usual activities in eight health domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. A higher score defines a more favorable health state scored on a 0-100 range for each of the 8 domain scales.

  19. Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 General Health Domain

    Time frame: 6 months after ICU discharge over the telephone general health perceptions

    Post-intensive care unit health-related quality of life will be assessed by the Short-Form-36 at 3- and 6-months after hospital discharge. The SF-36 tracks how well an individual feels and how well they are able to do their usual activities in eight health domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. A higher score defines a more favorable health state scored on a 0-100 range for each of the 8 domain scales.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • University of Minnesota

Registry information

Official study title

Efficacy of Self-management of Sedative Therapy by Ventilated ICU Patients

Important dates

Study start
2016
Primary completion
2024
Study completion
2024
First posted
Jun 30, 2016
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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