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Self-management of Sedative Therapy by Ventilated Patients

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ClinicalTrials.gov Identifier: NCT02819141
Recruitment Status : Recruiting
First Posted : June 30, 2016
Last Update Posted : February 23, 2022
Sponsor:
Collaborators:
University of Minnesota
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Linda L. Chlan, Ph.D., R.N., FAAN, Mayo Clinic

Tracking Information
First Submitted Date  ICMJE June 23, 2016
First Posted Date  ICMJE June 30, 2016
Last Update Posted Date February 23, 2022
Actual Study Start Date  ICMJE November 2016
Estimated Primary Completion Date November 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 18, 2018)
  • Changes in anxiety using the 100mm vertical visual analog scale [ Time Frame: 7 days ]
    Vertical visual analog scale will be used to measure level of state anxiety
  • Changes in duration of days receiving mechanical ventilation after study enrollment [ Time Frame: up to 6 months ]
    Patients' self-management of sedative therapy (SMST) using dexmedetomidine compared to usual sedation practices in mechanically ventilated subjects.
  • Changes in delirium using the CAM-ICU tool [ Time Frame: 7 days ]
    Confusion Assessment Method-ICU (CAM-ICU) will be used as a pre-enrollment delirium screening tool and to measure level of alertness and presence of delirium
Original Primary Outcome Measures  ICMJE
 (submitted: June 27, 2016)
  • Changes in duration of days receiving mechanical ventilation after study enrollment [ Time Frame: up to 6 months ]
    Patients' self-management of sedative therapy (SMST) using dexmedetomidine compared to usual sedation practices in mechanically ventilated subjects.
  • Changes in delirium using the CAM-ICU tool [ Time Frame: 7 days ]
    Confusion Assessment Method-ICU (CAM-ICU) will be used as a pre-enrollment delirium screening tool and to measure level of alertness and presence of delirium
  • Changes in anxiety using the 100mm vertical visual analog scale [ Time Frame: 7 days ]
    Vertical visual analog scale will be used to measure level of state anxiety
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2016)
  • Comparison of level of arousal and alertness using the Richmond Agitation-Sedation Scale [ Time Frame: 7 days ]
    The Richmond Agitation-Sedation Scale will be used to measure level of arousal and alertness
  • Comparison of sedative exposure (sedation frequency + sedation intensity) using electronic health record data of intravenous sedative medications. [ Time Frame: each 24-hour period, up to 7 days ]
    Frequency of intravenous sedatives medications sums the number of sedative medication doses administered to participant during each 4-hour time period during a 24-hour day. Sedation intensity is a score derived from aggregate dose frequency and dosing of each sedative medications administered to all study participants each 4-hour time period over the 24-hour study day. Scores are summed for the 24-hour period over the 6, 4-hour time blocks to produce a daily sedation intensity score.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 18, 2018)
  • Comparison of post-ICU physical status using the Katz Activities of Daily Living scale [ Time Frame: 3 and 6 months after ICU 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
  • Comparison of post-ICU functional status using the Functional Activities Questionnaire [ Time Frame: 3 and 6 months after ICU discharge over the telephone ]
    Functional status will be assessed by the Functional Activities Questionnaire that contains 10 questions that assess instrumental activities of daily living such as cooking, driving, managing finances.
  • Comparison of post-ICU psychological well-being status using the Patient Health Questionnaire [ Time Frame: 3 and 6 months after ICU discharge over the telephone ]
    Psychological well-being will be assessed by the Patient Health Questionnaire is a 9-item tool that tracks symptoms of major depression
  • Comparison of post-ICU psychological well-being status using the Posttraumatic Stress Disorder Checklist Event Specific scale [ Time Frame: 3 and 6 months after ICU discharge over the telephone ]
    Psychological well-being will also be assessed with the Posttraumatic Stress Disorder Checklist Event Specific toll to measure symptoms of posttraumatic stress disorder.
  • Comparison of post-intensive care unit health-related quality of life using the Short-Form 36 [ Time Frame: 3 and 6 months after ICU discharge over the telephone ]
    Post-intensive care unit health-related quality of life will be assessed by the Short-Form-36
  • Comparison of immediate post-extubation recollections of ICU using the Intensive Care Experience questionnaire [ Time Frame: 24 to 48 hours after extubation, 3 and 6 months after ICU discharge over the telephone ]
    Immediate post-extubation recollection of ICU experiences
  • 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 [ Time Frame: 24 to 48 hours after extubation ]
    Relationships among cognitive experiences, awareness, and mechanical ventilation complications
Original Other Pre-specified Outcome Measures
 (submitted: June 27, 2016)
  • Comparison of post-ICU physical status using the Katz Activities of Daily Living scale [ Time Frame: 3 and 6 months after ICU 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
  • Comparison of post-ICU functional status using the Functional Activities Questionnaire [ Time Frame: 3 and 6 months after ICU discharge over the telephone ]
    Functional status will be assessed by the Functional Activities Questionnaire that contains 10 questions that assess instrumental activities of daily living such as cooking, driving, managing finances.
  • Comparison of post-ICU psychological well-being status using the Patient Health Questionnaire [ Time Frame: 3 and 6 months after ICU discharge over the telephone ]
    Psychological well-being will be assessed by the Patient Health Questionnaire is a 9-item tool that tracks symptoms of major depression
  • Comparison of post-ICU psychological well-being status using the Posttraumatic Stress Disorder Checklist Event Specific scale [ Time Frame: 3 and 6 months after ICU discharge over the telephone ]
    Psychological well-being will also be assessed with the Posttraumatic Stress Disorder Checklist Event Specific toll to measure symptoms of posttraumatic stress disorder.
  • Comparison of post-intensive care unit health-related quality of life using the Short-Form 36 [ Time Frame: 3 and 6 months after ICU discharge over the telephone ]
    Post-intensive care unit health-related quality of life will be assessed by the Short-Form-36
 
Descriptive Information
Brief Title  ICMJE Self-management of Sedative Therapy by Ventilated Patients
Official Title  ICMJE Efficacy of Self-management of Sedative Therapy by Ventilated ICU Patients
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Critical Illness
  • Anxiety
  • Respiratory Failure
Intervention  ICMJE Drug: Dexmedetomidine
Patient will receive a maintenance intravenous infusion of medication (Dexmedetomidine) and have access to self-controlled sedation medication (Dexmedetomidine) for anxiety.
Other Name: Precedex
Study Arms  ICMJE
  • No Intervention: Control
    These patient will get usual care - sedation administered by ICU Nurses as deemed necessary by primary care team
  • Experimental: Dexmedetomidine
    These patients will receive a basal intravenous infusion of medication (Dexmedetomidine) and have access to self-administered sedation medication (Dexmedetomidine) for anxiety.
    Intervention: Drug: Dexmedetomidine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 27, 2016)
228
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2024
Estimated Primary Completion Date November 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Linda L Chlan, RN, PhD chlan.linda@mayo.edu
Contact: Jessica Ask, BSN 507-2558965 ask.jessica@mayo.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02819141
Other Study ID Numbers  ICMJE 16-000417
R01HL030881 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Linda L. Chlan, Ph.D., R.N., FAAN, Mayo Clinic
Original Responsible Party Linda L. Chlan, Ph.D., R.N., Mayo Clinic, PI
Current Study Sponsor  ICMJE Mayo Clinic
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • University of Minnesota
  • National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Linda L Chlan Mayo Clinic
PRS Account Mayo Clinic
Verification Date February 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP