AnesthesiaNCT02529696
Measuring Sedation in the Intensive Care Unit Using Wireless Accelerometers
An observational study of Anesthesia, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Accelerometer
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2015to 31 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving care from the neuro ICU at the University of Minnesota will be eligible for participation.
Who may be able to join
- Admitted to the neuro ICU at University of Minnesota
Who cannot join
- Unable to wear accelerometer device
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
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.
Read the 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.
- Conditions
- Anesthesia
- Being tested
- Accelerometer
- Keywords
- accelerometer, RASS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AccelerometerDevice
Measures patient movement
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Accelerometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accelerometer movement
Movement during stay in the ICU.
Measured: Duration of ICU stay: estimated to be one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2015 (estimated)
- Study start30 Sep 2015
- Primary completion31 May 2018
- Study completion31 May 2019
Why it stopped: Low enrollment, unable to power adequately
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Darrow, MD/MPH, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02529696
- Sponsor's protocol ID
- 1502M62761
- Status last verified
- Jun 2022
- First submitted
- 10 Aug 2015
- Last updated
- 28 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Sedation in the Intensive Care Unit Using Wireless Accelerometers
- ClinicalTrials.gov ID
- NCT02529696
- Acronym / sponsor ID
- 1502M62761
- Conditions
- Anesthesia
- Keywords
- accelerometer, RASS
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low enrollment, unable to power adequately
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 30 Sep 2015 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 20 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Medical device, accelerometer | – | Device: AccelerometerA 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving care from the neuro ICU at the University of Minnesota will be eligible for participation.
Key inclusion criteria (1 listed)
- Admitted to the neuro ICU at University of Minnesota
Key exclusion criteria (1 listed)
- Unable to wear accelerometer device
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AccelerometerMeasures patient movement | Device | Medical device, accelerometer |
Primary outcome
Accelerometer movement
Time frame: Duration of ICU stay: estimated to be one week
Movement during stay in the ICU.
Results and safety
The study was stopped early (reason given: Low enrollment, unable to power adequately). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Darrow, MD/MPH principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low enrollment, unable to power adequately). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accelerometer movement (time frame: Duration of ICU stay: estimated to be one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2022; AzTrials last refreshed its copy on 28 Oct 2026.