Self-management of Sedative Therapy by Ventilated Patients

Phase 2

Active, not recruiting

• Conditions: Critical Illness; Anxiety; Respiratory Failure
• Interventions: Drug: Dexmedetomidine

• Registration Number: NCT02819141
• Lead Sponsor: Mayo Clinic

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-06-23
• Study First Submitted QC: 2016-06-27
• Study First Posted: 2016-06-30
• Study Start: 2016-11
• Primary Completion: 2024-04-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-26
• Last Update Posted: 2024-07-29
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 190

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Changes in anxiety using the 100mm vertical visual analog scale	7 days	Vertical visual analog scale will be used to measure level of state anxiety
Changes in duration of days receiving mechanical ventilation after study enrollment	up to 6 months	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	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

Name	Time	Method
Comparison of level of arousal and alertness using the Richmond Agitation-Sedation Scale	7 days	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.	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.

Trial Locations

Locations (2)

School of Medicine, University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States