Trial record 6 of 1582 for:    "Mayo Clinic" [Exact]

Self-management of Sedative Therapy by Ventilated Patients

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2016 by Mayo Clinic
Sponsor:
Collaborator:
University of Minnesota, MN
Information provided by (Responsible Party):
Linda L. Chlan, Ph.D., R.N., Mayo Clinic
ClinicalTrials.gov Identifier:
NCT02819141
First received: June 23, 2016
Last updated: June 27, 2016
Last verified: June 2016
  Purpose
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.

Condition Intervention Phase
Critical Illness
Anxiety
Respiratory Failure
Drug: Dexmedetomidine
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Self-management of Sedative Therapy by Ventilated ICU Patients

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Changes in duration of days receiving mechanical ventilation after study enrollment [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Vertical visual analog scale will be used to measure level of state anxiety


Secondary Outcome Measures:
  • Comparison of level of arousal and alertness using the Richmond Agitation-Sedation Scale [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Post-intensive care unit health-related quality of life will be assessed by the Short-Form-36


Estimated Enrollment: 228
Study Start Date: September 2016
Estimated Study Completion Date: November 2021
Estimated Primary Completion Date: April 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
These patient will get usual care - sedation administered by ICU Nurses as deemed necessary by primary care team
Experimental: Intervention
These patients will receive a basal intravenous infusion of medication (Dexmedetomidine) and have access to self-administered sedation medication (Dexmedetomidine) for anxiety.
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

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.

An exploratory aim is to compare post-ICU outcomes (physical/functional status, psychological well-being, and health-related quality of life) between MVPs randomized to SMST and those receiving nurse-administered sedative therapy.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria - Subjects may be included in the study if all of the following conditions exist:

  1. Subject is acutely mechanically ventilated during the current hospitalization.
  2. Subject is expected to require mechanical ventilation for at least an additional 48 hours after enrollment.
  3. Subject must pass pre-PCS screening test (see below 4.4) and be assessed RASS -1 to +1
  4. Subject Age ≥ 18 years
  5. Subject or their proxy is capable of providing informed consent

Exclusion Criteria - Subjects will be excluded from the study if any of the following conditions exist:

  1. Aggressive ventilatory support such as positive end expiratory pressure > 15 cm of water or prone ventilation.
  2. Hypotension requiring vasopressors (systolic blood pressure < 85 mmHg).
  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
  7. General anesthesia within 24 hours prior to enrollment.
  8. Acute stroke or uncontrolled seizures.
  9. Acute myocardial infarction
  10. Severe cognition or communication problems (such as coma, deafness without signing literacy, physician-documented dementia)
  11. Assessed RASS -2, -3, -4, -5 or RASS +2,+3, +4
  12. Chronic ventilator support in place of resident prior to current hospitalization.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02819141

Contacts
Contact: Linda L Chlan, RN, PhD chlan.linda@mayo.edu
Contact: Rahul Kashyap, MBBS 507-255-7196 kashyap.rahul@mayo.edu

Locations
United States, Minnesota
School of Medicine, University of Minnesota Not yet recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Craig R Weinert, MD    612-626-4607    weine006@umn.edu   
Principal Investigator: Craig R Weinert, MD         
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
University of Minnesota, MN
Investigators
Principal Investigator: Linda L Chlan Mayo Clinic
  More Information

Responsible Party: Linda L. Chlan, Ph.D., R.N., PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02819141     History of Changes
Other Study ID Numbers: 16-000417 
Study First Received: June 23, 2016
Last Updated: June 27, 2016
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Respiratory Insufficiency
Critical Illness
Respiration Disorders
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 24, 2016