Measuring Sedation in the Intensive Care Unit Using Wireless Accelerometers

June 21, 2022 updated by: University of Minnesota
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The goal of the study is to use accelerometers to track patient movement while under sedation in the ICU. Analysis of patient movement may reveal objective means to measuring patient level of sedation. Average length of stay is estimated to be one week.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients receiving care from the neuro ICU at the University of Minnesota will be eligible for participation.

Description

Inclusion Criteria:

  • Admitted to the neuro ICU at University of Minnesota

Exclusion Criteria:

  • Unable to wear accelerometer device

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Device: Accelerometer
Measures patient movement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accelerometer movement
Time Frame: Duration of ICU stay: estimated to be one week
Movement during stay in the ICU.
Duration of ICU stay: estimated to be one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Investigators

  • Principal Investigator: David Darrow, MD/MPH, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 30, 2015

Primary Completion (ACTUAL)

May 31, 2018

Study Completion (ACTUAL)

May 31, 2019

Study Registration Dates

First Submitted

August 10, 2015

First Submitted That Met QC Criteria

August 18, 2015

First Posted (ESTIMATE)

August 20, 2015

Study Record Updates

Last Update Posted (ACTUAL)

June 28, 2022

Last Update Submitted That Met QC Criteria

June 21, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1502M62761

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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