Self-management of Sedative Therapy by Ventilated Patients

NCT02819141 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 16-0004175R01HL130881
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 2

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.

Conditions

Critical Illness; Anxiety; Respiratory Failure

Outcome Measures

Primary Outcomes (3)

• Anxiety Rating Using the 100mm Vertical Visual Analog Scale

  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.

  7 days

• Duration of Mechanical Ventilatory Support After Study Enrollment

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

  7 days

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

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

  7 days

Secondary Outcomes (3)

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

  7 days

• 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.

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

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

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

Other Outcomes (19)

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

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

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

  3 and 6 months after ICU discharge over the telephone

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

  3 months and 6 months after ICU discharge over the telephone

Study Arms (2)

Control

NO INTERVENTION

These patient will get usual care - sedation administered by ICU Nurses as deemed necessary by primary care team

Dexmedetomidine

EXPERIMENTAL

These patients will receive a basal intravenous infusion of medication (Dexmedetomidine) and have access to self-administered sedation medication (Dexmedetomidine) for anxiety.

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

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

Also known as: Precedex

Dexmedetomidine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• University of Minnesota: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

School of Medicine, University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (3)

• 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.

  PMID: 30540694 BACKGROUND

• 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.

  PMID: 35578315 BACKGROUND

• Chlan LL, Tracy MF, Ask J, Lal A, Mandrekar J. The impact of the COVID-19 pandemic on ICU clinical trials: a description of one research team's experience. Trials. 2023 May 11;24(1):321. doi: 10.1186/s13063-023-07355-4.

  PMID: 37165383 BACKGROUND

MeSH Terms

Conditions

Critical Illness; Anxiety Disorders; Respiratory Insufficiency

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mental Disorders; Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

The corona virus (COVID-19) global pandemic adversely impacted the ICU clinical trial. The pandemic influenced many aspects of patient availability for enrollment, changes to patient management including sedation regimens and clinical practice in the care of critically ill patients receiving mechanical ventilatory support. Fewer than planned patients randomized to dexmedetomidine self-management of sedative therapy actually received the experimental intervention, resulting in unbalanced numbers.

Results Point of Contact

• Title: Dr. Linda L. Chlan, Professor of Nursing
• Organization: Mayo Clinic

chlan.linda@mayo.edu

507-255-7859

Study Officials

• Linda L Chlan, RN, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: June 23, 2016
• First Posted: June 30, 2016
• Study Start: November 1, 2016
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 2, 2025
• Results First Posted: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)