NCT02529696

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

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 20, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

September 30, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
Last Updated

June 28, 2022

Status Verified

June 1, 2022

Enrollment Period

2.7 years

First QC Date

August 10, 2015

Last Update Submit

June 21, 2022

Conditions

Keywords

accelerometerRASS

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.

Device: Accelerometer

Interventions

Measures patient movement

Medical device, accelerometer

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

Study Officials

  • David Darrow, MD/MPH

    University of Minnesota

    PRINCIPAL INVESTIGATOR

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

Locations