Trial · NCT02819141

Self-management of Sedative Therapy by Ventilated Patients

NCT02819141, Phase 2, Phase 3, Completed, Mayo Clinic; results first posted 2025-10-02

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Self-management of Sedative Therapy by Ventilated Patients. Trials, record NCT02819141. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02819141

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Self-management of Sedative Therapy by Ventilated Patients
NCT number: NCT02819141
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 161 participants, actual
Lead sponsor: Mayo Clinic
Conditions: Critical Illness, Anxiety, Respiratory Failure
Interventions: Dexmedetomidine
First posted: 2016-06-30
Last updated: 2025-10-02
Results first posted: 2025-10-02
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.

Source ClinicalTrials.gov

Registered outcomes25

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Anxiety Rating Using the 100mm Vertical Visual Analog Scale	7 days	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.
Primary	Duration of Mechanical Ventilatory Support After Study Enrollment	7 days	Duration of time (hours) patients received mechanical ventilatory support after randomization to either Control or dexmedetomidine self-management of sedative therapy to extubation.
Primary	Incidence of Delirium Using the Confusion Assessment Method-ICU (CAM-ICU)	7 days	Confusion Assessment Method-ICU (CAM-ICU) used to assess for the presence (CAM-ICU+) or absence (CAM-ICU-) of delirium at each assessment.
Secondary	Comparison of Level of Arousal and Agitation Using the Richmond Agitation-Sedation Scale (RASS)	7 days	The Richmond Agitation-Sedation Scale (RASS) was used to assess the level of alertness and agitation in enrolled patients. Scores range from -5 to +4. RASS 0/zero indicates alert and calm patient. Negative scores (-1 to -5) indicate increasing level of sedation with -5 indicating unarousable. Positive scores indicate increasing agitation (+1 to +4) with +4 indicating a combative patient. For enrolled study patients, RASS score -2 (light sedation) to +1 (restless) was considered in range. We report here the total number of patients assessed as outside the desirable range of RASS score -5 to -3 and +2 to +4 by each ICU study day.
Secondary	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	Sedation intensity combines the number of sedative doses and the dose amount of any of 9 intravenous (IV) sedative medications (lorazepam, midazolam, propofol, morphine, hydromorphone, dexmedetomidine, fentanyl, haloperidol, ketamine) recorded in the electronic health record, summarized over all patients and time periods each day to obtain medians and quartiles. Each of the 9 sedative drugs administered during each 4-hr period is then assigned a ranking: 0 for drug not used, 1 for the bottom quartile, 2 for the second quartile, 3 for the third, and 4 for the fourth. A score is determined by summing for the 24-hr day over the 6, 4-hour blocks to produce a daily Sedation Intensity Score from 0-36, higher score more intense dosing received of sedative medications.
Secondary	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	Sedation Frequency is the number of individual intravenous (IV) sedative medication(s) doses administered to patients over each 24-hour day of lorazepam, midazolam, propofol, morphine, hydromorphone, dexmedetomidine, fentanyl, haloperidol, ketamine. Sedation frequency ranges from 0-216 with a higher number indicating more frequent receipt of a sedative medication(s).
Other	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	Physical status will be assessed by the Katz Activities of Daily Living scale to assess basic physical abilities like bathing, feeding with 6 questions. Higher scores of 6 indicates the individual is independent, whereas a score of 0 indicates the individual is very dependent.
Other	Comparison of Post-ICU Psychological Well-being Status Using the Patient Health Questionnaire-9	3 and 6 months after ICU discharge over the telephone	Psychological well-being will be assessed by the Patient Health Questionnaire (PHQ-9) is a 9-item tool that tracks symptoms of major depression. Scores range from 9-36, with higher scores indicating altered psychological well-being.
Other	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	Psychological well-being will be assessed with the Posttraumatic Stress Disorder Checklist Event Specific (PCL) to measure symptoms of posttraumatic stress disorder after a stressful life experience of ICU admission. Scores range from 17-85 with higher scores indicating being symptomatic for posttraumatic stress.
Other	Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Physical Function Domain	3 months after ICU discharge over the telephone Physical Function Domain	Post-intensive care unit health-related quality of life will be assessed by the Short-Form-36 (SF-36) at 3- and 6-months after hospital discharge. The SF-36 tracks how well an individual feels and how well they are able to do their usual activities in eight health domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. A higher score defines a more favorable health state scored on a 0-100 range for each of the 8 domain scales.

1 to 10 of 25Source ClinicalTrials.gov

See all 25 registered outcomes

Outcomes25

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Anxiety Rating Using the 100mm Vertical Visual Analog Scale	7 days	Not all enrolled patients able to respond to each assessment time point for anxiety ratings. They may have been extubated and completed the ICU study phase, withdrew from the study, or died.	score on a scale	MEAN
PRIMARY	Duration of Mechanical Ventilatory Support After Study Enrollment	7 days	Includes all patients enrolled who were randomized using an Intention to treat analysis	hours	MEAN
PRIMARY	Incidence of Delirium Using the Confusion Assessment Method-ICU (CAM-ICU)	7 days		participants CAM-ICU+	NUMBER
SECONDARY	Comparison of Level of Arousal and Agitation Using the Richmond Agitation-Sedation Scale (RASS)	7 days	Not all patients were available for RASS assessment at each time point as some patients were extubated and completed the study, or were withdrawn or died.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	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	Patients exit the study at various times over the 7-day ICU study period leading to a different number of patients available for analysis on each ICU study day.	score on a scale	MEAN
OTHER_PRE_SPECIFIED	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	Different number of patients responded to the telephone call at each time point~.	score on a scale	MEAN
OTHER_PRE_SPECIFIED	Comparison of Post-ICU Psychological Well-being Status Using the Patient Health Questionnaire-9	3 and 6 months after ICU discharge over the telephone	3 month PHQ-9	score on a scale	MEAN
OTHER_PRE_SPECIFIED	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		score on a scale	MEAN
OTHER_PRE_SPECIFIED	Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Physical Function Domain	3 months after ICU discharge over the telephone Physical Function Domain	Physical Function at 3 months	score on a scale	MEAN
OTHER_PRE_SPECIFIED	Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Physical Function Domain	6 months after ICU discharge over the telephone Physical Function Domain	Physical Function at 6 months	score on a scale	MEAN

1 to 10 of 25Source ClinicalTrials.gov

See all 25 outcomes

Results by group160

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Anxiety Rating Using the 100mm Vertical Visual Analog Scale	Control	Day 1 morning	44.4	Standard Deviation 33.2	score on a scale
Anxiety Rating Using the 100mm Vertical Visual Analog Scale	Dexmedetomidine	Day 1 morning	43.4	Standard Deviation 33.4	score on a scale
Anxiety Rating Using the 100mm Vertical Visual Analog Scale	Control	Day 1 afternoon	40.5	Standard Deviation 31.8	score on a scale
Anxiety Rating Using the 100mm Vertical Visual Analog Scale	Dexmedetomidine	Day 1 afternoon	33.1	Standard Deviation 30.9	score on a scale
Anxiety Rating Using the 100mm Vertical Visual Analog Scale	Control	Day 1 evening	45.1	Standard Deviation 32.4	score on a scale
Anxiety Rating Using the 100mm Vertical Visual Analog Scale	Dexmedetomidine	Day 1 evening	40.9	Standard Deviation 35.7	score on a scale
Anxiety Rating Using the 100mm Vertical Visual Analog Scale	Control	Day 2 morning	49.8	Standard Deviation 30.9	score on a scale
Anxiety Rating Using the 100mm Vertical Visual Analog Scale	Dexmedetomidine	Day 2 morning	44.6	Standard Deviation 34.4	score on a scale
Anxiety Rating Using the 100mm Vertical Visual Analog Scale	Control	Day 2 afternoon	41.9	Standard Deviation 33.4	score on a scale
Anxiety Rating Using the 100mm Vertical Visual Analog Scale	Dexmedetomidine	Day 2 afternoon	41.4	Standard Deviation 38.5	score on a scale

1 to 10 of 160Source ClinicalTrials.gov

See all 160 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Control	81
Overall Study	STARTED	Dexmedetomidine	80
Overall Study	COMPLETED	Control	75
Overall Study	COMPLETED	Dexmedetomidine	60
Overall Study	NOT COMPLETED	Control	6
Overall Study	NOT COMPLETED	Dexmedetomidine	20

Source ClinicalTrials.gov

Adverse events16

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Hypotension	Cardiac disorders	Control	23	81	23
other	Hypotension	Cardiac disorders	Dexmedetomidine	22	80	22
other	Bradycardia	Cardiac disorders	Control	0	81	0
other	Bradycardia	Cardiac disorders	Dexmedetomidine	2	80	2
other	Hypertension	Cardiac disorders	Control	1	81	1
other	Hypertension	Cardiac disorders	Dexmedetomidine	0	80	0
other	Tachycardia	Cardiac disorders	Control	5	81	5
other	Tachycardia	Cardiac disorders	Dexmedetomidine	0	80	0
serious	Worsening respiratory failure	Respiratory, thoracic and mediastinal disorders	Control	2	81	2
serious	Worsening respiratory failure	Respiratory, thoracic and mediastinal disorders	Dexmedetomidine	5	80	5

1 to 10 of 16Source ClinicalTrials.gov

See all 16 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Control	1	81
Total, all-cause mortality	Dexmedetomidine	0	80
Total, other adverse events	Control	29	81
Total, other adverse events	Dexmedetomidine	24	80
Total, serious adverse events	Control	5	81
Total, serious adverse events	Dexmedetomidine	12	80

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
30540694	BACKGROUND	PubMed
35578315	BACKGROUND	PubMed
37165383	BACKGROUND	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01HL130881	Efficacy of self-management of sedative therapy by ventilated ICU patients	CHLAN, LINDA L; TRACY, MARY FRANCES; WEINERT, CRAIG R	MAYO CLINIC ROCHESTER	NATIONAL HEART, LUNG, AND BLOOD INSTITUTE	2016 to 2021

Source NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Dexmedetomidine vs Control: deaths from any cause	Trial comparisons
Dexmedetomidine vs Control: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02819141

GET https://conductscience.org/api/trials/v1/NCT02819141/registered?page=2

API reference For AI assistants