Study Stopped
Low enrollment, unable to power adequately
Measuring Sedation in the Intensive Care Unit Using Wireless Accelerometers
1 other identifier
observational
60
1 country
1
Brief Summary
Maintenance of analgesia during a patient stay in the hospital has been an important area of investigation after demonstrating a direct correlation between level of sedation and mortality in the ICU setting. This study will investigate the use of accelerometers in determining patient sedation level.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2015
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 10, 2015
CompletedFirst Posted
Study publicly available on registry
August 20, 2015
CompletedStudy Start
First participant enrolled
September 30, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2019
CompletedJune 28, 2022
June 1, 2022
2.7 years
August 10, 2015
June 21, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Accelerometer movement
Movement during stay in the ICU.
Duration of ICU stay: estimated to be one week
Study Arms (1)
Medical device, accelerometer
A wrist and chest accelerometer will be worn for the duration of stay in the ICU. Data will be generated from patient movement and recorded. Neither the generated data or the worn devices will influence care team's decisions during the patients' stay.
Interventions
Eligibility Criteria
Patients receiving care from the neuro ICU at the University of Minnesota will be eligible for participation.
You may qualify if:
- Admitted to the neuro ICU at University of Minnesota
You may not qualify if:
- Unable to wear accelerometer device
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Study Officials
- PRINCIPAL INVESTIGATOR
David Darrow, MD/MPH
University of Minnesota
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2015
First Posted
August 20, 2015
Study Start
September 30, 2015
Primary Completion
May 31, 2018
Study Completion
May 31, 2019
Last Updated
June 28, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share