Self-management of Sedative Therapy by Ventilated Patients

Last updated: July 26, 2024
Sponsor: Mayo Clinic
Overall Status: Active - Not Recruiting

Phase

2/3

Condition

Lung Injury

Respiratory Failure

Treatment

Dexmedetomidine

Clinical Study ID

NCT02819141
16-000417
R01HL030881
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subject is acutely mechanically ventilated during the current hospitalization.

  2. Subject is currently receiving a continuous intravenous infusion of asedative/opioid medication(s) or has received at least one intravenous bolus dose ofa 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 beassessed 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

Exclusion Criteria:

  1. Aggressive ventilatory support or prone ventilation.

  2. Hypotension (systolic blood pressure < 85 mmHg) requiring a vasopressor at a dosegreater than norepinephrine or epinephrine 0.15 mcg/kg/min or vasopressin > 2.4units per hour. Subjects will be excluded if they require more than one continuousinfusion of a catecholamine vasopressor medication simultaneously. Subjects will beexcluded if the vasopressor dose was higher than norepinephrine or epinephrine 0.15mcg/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 beingused to increase heart rate, rather than as a vasopressor for hypotension, subjectwill 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 signingliteracy, 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.

Study Design

Total Participants: 190
Treatment Group(s): 1
Primary Treatment: Dexmedetomidine
Phase: 2/3
Study Start date:
November 01, 2016
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • School of Medicine, University of Minnesota

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Mayo Clinic in Rochester

    Rochester, Minnesota 55905
    United States

    Site Not Available

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