Self-management of Sedative Therapy by Ventilated Patients

• ClinicalTrials.gov Identifier: NCT02819141
• Recruitment Status: Recruiting
• First Posted: June 30, 2016
• Last Update Posted: February 13, 2023
• Sponsor: Mayo Clinic
• 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

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Critical Illness; Anxiety; Respiratory Failure	Drug: Dexmedetomidine	Phase 2; Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 228 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy of Self-management of Sedative Therapy by Ventilated ICU Patients
• Actual Study Start Date: November 2016
• Estimated Primary Completion Date: December 2023
• Estimated Study Completion Date: July 2024

Arms and Interventions

Arm	Intervention/treatment
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.	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

Outcome Measures

Primary Outcome Measures :

1. 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
2. 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.
3. 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

Secondary Outcome Measures :

1. 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
2. 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.

Other Outcome Measures:

1. 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
2. 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.
3. 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
4. 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.
5. 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
6. 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
7. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Linda L Chlan, RN, PhD; chlan.linda@mayo.edu

Contact: Karen Cavanaugh, RN; 507-538-7178; cavanaugh.karen@mayo.edu

Locations

United States, Minnesota

School of Medicine, University of Minnesota; 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; Recruiting

Rochester, Minnesota, United States, 55905

Contact: Karen Cavanaugh, RN 507-538-7178 cavanaugh.karen@mayo.edu

Contact: Pamela Peterson, BNS, RN 507-255-0068 peterson.pamela@mayo.edu

Principal Investigator: Linda L Chlan, Ph.D., RN

Principal Investigator: Craig R Weinert, MD, MPH

Principal Investigator: Mary F Tracy, PhD, RN

Sponsors and Collaborators

Mayo Clinic

University of Minnesota

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Linda L Chlan, RN, PhD; Mayo Clinic

More Information

Publications:

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.

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.

• Responsible Party: Linda L. Chlan, Ph.D., R.N., FAAN, PI, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT02819141
• Other Study ID Numbers: 16-000417; R01HL030881 ( U.S. NIH Grant/Contract )
• First Posted: June 30, 2016
• Last Update Posted: February 13, 2023
• Last Verified: February 2023

Individual Participant Data (IPD) Sharing Statement:

• 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