Self-management of Sedative Therapy by Ventilated Patients

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02819141
• Other study ID #: 16-000417
• Secondary ID: R01HL030881
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: November 2016
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 190
• Est. completion date: December 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Critical Illness
• Respiratory Failure
• Respiratory Insufficiency

Intervention

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

Locations

Country	Name	City	State
United States	School of Medicine, University of Minnesota	Minneapolis	Minnesota
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
Mayo Clinic	National Heart, Lung, and Blood Institute (NHLBI), University of Minnesota

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Comparison of post-ICU physical status using the Katz Activities of Daily Living scale	Physical status will be assessed by the Katz Activities of Daily Living scale to assess basic physical abilities like bathing, feeding with 6 questions	3 and 6 months after ICU discharge over the telephone
Other	Comparison of post-ICU functional status using the Functional Activities Questionnaire	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 and 6 months after ICU discharge over the telephone
Other	Comparison of post-ICU psychological well-being status using the Patient Health Questionnaire	Psychological well-being will be assessed by the Patient Health Questionnaire is a 9-item tool that tracks symptoms of major depression	3 and 6 months after ICU discharge over the telephone
Other	Comparison of post-ICU psychological well-being status using the Posttraumatic Stress Disorder Checklist Event Specific scale	Psychological well-being will also be assessed with the Posttraumatic Stress Disorder Checklist Event Specific toll to measure symptoms of posttraumatic stress disorder.	3 and 6 months after ICU discharge over the telephone
Other	Comparison of post-intensive care unit health-related quality of life using the Short-Form 36	Post-intensive care unit health-related quality of life will be assessed by the Short-Form-36	3 and 6 months after ICU discharge over the telephone
Other	Comparison of immediate post-extubation recollections of ICU using the Intensive Care Experience questionnaire	Immediate post-extubation recollection of ICU experiences	24 to 48 hours after extubation, 3 and 6 months after ICU discharge over the telephone
Other	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	Relationships among cognitive experiences, awareness, and mechanical ventilation complications	24 to 48 hours after extubation
Primary	Changes in anxiety using the 100mm vertical visual analog scale	Vertical visual analog scale will be used to measure level of state anxiety	7 days
Primary	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.	up to 6 months
Primary	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	7 days
Secondary	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	7 days
Secondary	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.	each 24-hour period, up to 7 days