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Self-management of Sedative Therapy by Ventilated Patients

Primary Purpose

Critical Illness, Anxiety, Respiratory Failure

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Dexmedetomidine

About this trial

This is an interventional treatment trial for Critical Illness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.

Sites / Locations

School of Medicine, University of MinnesotaRecruiting
Mayo Clinic in RochesterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Dexmedetomidine

Arm Description

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

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

Outcomes

Primary Outcome Measures

Changes in anxiety using the 100mm vertical visual analog scale

Vertical visual analog scale will be used to measure level of state anxiety

Changes in duration of days receiving mechanical ventilation after study enrollment

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

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

Comparison of level of arousal and alertness using the Richmond Agitation-Sedation Scale

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.

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.

Full Information

NCT ID

NCT02819141

First Posted

June 23, 2016

Last Updated

February 9, 2023

Sponsor

Mayo Clinic

Collaborators

University of Minnesota, National Heart, Lung, and Blood Institute (NHLBI)

1. Study Identification

Unique Protocol Identification Number

NCT02819141

Brief Title

Self-management of Sedative Therapy by Ventilated Patients

Official Title

Efficacy of Self-management of Sedative Therapy by Ventilated ICU Patients

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 2016 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

Collaborators

University of Minnesota, National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Critical Illness, Anxiety, Respiratory Failure

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

228 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

No Intervention

Arm Description

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

Arm Title

Dexmedetomidine

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Dexmedetomidine

Other Intervention Name(s)

Precedex

Intervention Description

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

Primary Outcome Measure Information:

Title

Changes in anxiety using the 100mm vertical visual analog scale

Description

Vertical visual analog scale will be used to measure level of state anxiety

Time Frame

7 days

Title

Changes in duration of days receiving mechanical ventilation after study enrollment

Description

Patients' self-management of sedative therapy (SMST) using dexmedetomidine compared to usual sedation practices in mechanically ventilated subjects.

Time Frame

up to 6 months

Title

Changes in delirium using the CAM-ICU tool

Description

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

Time Frame

7 days

Secondary Outcome Measure Information:

Title

Comparison of level of arousal and alertness using the Richmond Agitation-Sedation Scale

Description

The Richmond Agitation-Sedation Scale will be used to measure level of arousal and alertness

Time Frame

7 days

Title

Comparison of sedative exposure (sedation frequency + sedation intensity) using electronic health record data of intravenous sedative medications.

Description

Time Frame

each 24-hour period, up to 7 days

Other Pre-specified Outcome Measures:

Title

Comparison of post-ICU physical status using the Katz Activities of Daily Living scale

Description

Physical status will be assessed by the Katz Activities of Daily Living scale to assess basic physical abilities like bathing, feeding with 6 questions

Time Frame

3 and 6 months after ICU discharge over the telephone

Title

Comparison of post-ICU functional status using the Functional Activities Questionnaire

Description

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.

Time Frame

3 and 6 months after ICU discharge over the telephone

Title

Comparison of post-ICU psychological well-being status using the Patient Health Questionnaire

Description

Psychological well-being will be assessed by the Patient Health Questionnaire is a 9-item tool that tracks symptoms of major depression

Time Frame

3 and 6 months after ICU discharge over the telephone

Title

Comparison of post-ICU psychological well-being status using the Posttraumatic Stress Disorder Checklist Event Specific scale

Description

Psychological well-being will also be assessed with the Posttraumatic Stress Disorder Checklist Event Specific toll to measure symptoms of posttraumatic stress disorder.

Time Frame

3 and 6 months after ICU discharge over the telephone

Title

Comparison of post-intensive care unit health-related quality of life using the Short-Form 36

Description

Post-intensive care unit health-related quality of life will be assessed by the Short-Form-36

Time Frame

3 and 6 months after ICU discharge over the telephone

Title

Comparison of immediate post-extubation recollections of ICU using the Intensive Care Experience questionnaire

Description

Immediate post-extubation recollection of ICU experiences

Time Frame

24 to 48 hours after extubation, 3 and 6 months after ICU discharge over the telephone

Title

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

Description

Relationships among cognitive experiences, awareness, and mechanical ventilation complications

Time Frame

24 to 48 hours after extubation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Linda L Chlan, RN, PhD

chlan.linda@mayo.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Karen Cavanaugh, RN

Phone

507-538-7178

cavanaugh.karen@mayo.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Linda L Chlan, RN, PhD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

School of Medicine, University of Minnesota

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55455

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Craig R Weinert, MD

Phone

612-626-4607

weine006@umn.edu

First Name & Middle Initial & Last Name & Degree

Craig R Weinert, MD

Facility Name

Mayo Clinic in Rochester

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Karen Cavanaugh, RN

Phone

507-538-7178

cavanaugh.karen@mayo.edu

First Name & Middle Initial & Last Name & Degree

Pamela Peterson, BNS, RN

Phone

507-255-0068

peterson.pamela@mayo.edu

First Name & Middle Initial & Last Name & Degree

Linda L Chlan, Ph.D., RN

First Name & Middle Initial & Last Name & Degree

Craig R Weinert, MD, MPH

First Name & Middle Initial & Last Name & Degree

Mary F Tracy, PhD, RN

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

30540694

Citation

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.

Results Reference

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PubMed Identifier

35578315

Citation

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.

Results Reference

background

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Self-management of Sedative Therapy by Ventilated Patients

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