Critical IllnessCOST_2NCT00734409
Combining Objective and Subjective Sedation Assessment Tools
A study testing Bispectral Index (BIS) Monitor in people with Critical Illness, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to determine if the use of a device called the BIS monitor in addition to the Richmond Agitation Sedation Scale will give better assessment of a subject's level of sedation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- Bispectral Index (BIS) Monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Jul 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient in the ICU
- continuous IV sedation with propofol midazolam or dexmedetomidine
- age > 18
- expected to require mechanical ventilation for >=48 hours
Who cannot join
- prisoners
- no available space on forehead
- continuous electroencephalography(EEG) monitoring
- bifrontal brain injury
- barbiturate coma therapy
- known hypersensitivity to study medications
Show all 9Show fewer
- high risk for ethanol (ETOH) withdrawal
- resuscitation from cardiac arrest without recovery of mental status
- moribund clinical state (death expected within 48 hours)
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Health System
Durham, North Carolina, 27710
About this study
Official title: Combining Objective and Subjective Sedation Assessment Tools - Second Study
The purpose of this study is to determine if the use of a device called the BIS monitor in addition to the Richmond Agitation Sedation Scale will give better assessment of a subject's level of sedation.
Read the detailed description
Patients in the intensive care unit (ICU) who require a ventilator to help them breathe also require sedation in order to keep them comfortable and prevent injury. The national guidelines for sedation management include a daily interruption of sedation performed once each morning. To determine the amount of sedation needed, the current standard practice is to use a system called the Richmond Agitation-Sedation Scale (RASS). The patient is stimulated by calling their name or by tapping their shoulder until the patient's responses indicate that a satisfactory level of sedation has been achieved.
The purpose of this study is to determine if the use of a device called the BIS monitor in addition to the RASS will give better assessment of a subject's level of sedation. The BIS monitor is a sensor strip taped to the forehead and attached to a device that reads electrical activity from the brain. It is approved by the U.S. Food and Drug Administration (FDA) for monitoring patients under sedation.
- Conditions
- Critical Illness
- Being tested
- Bispectral Index (BIS) Monitor
- Keywords
- Mechanical ventilation, Human, conscious sedation, bispectral index, monitoring, critical care, propofol
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bispectral Index (BIS) MonitorDevice
Also called Richmond agitation sedation scale, neurofunction monitor
BIS monitoring in addition to RASS assessments
| Study group | Role | What they receive |
|---|---|---|
| RASS plus (BIS) | Experimental | Participants in this arm will receive sedation assessment with the RASS scale augmented with Bispectral Index (BIS) Monitor Receives: Device: Bispectral Index (BIS) Monitor |
| RASS only | No intervention | Participants will receive sedation assessment only using the RASS scale which is the standard of care at our institution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Sedative Use
The mean amount of propofol used on each patient while the patient was in the ICU and receiving mechanical ventilation.
Measured: Intensive Care Unit (ICU) stay through discharge
Secondary outcomes (2)
Unplanned Self-device Removal Events
The number of unplanned self-device removal events that took place during the study period.
Measured: ICU stay through discharge
Mean Days on Mechanical Ventilation
The mean number of days that the patients were on mechanical ventilation.
Measured: ICU stay- through discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2008 (estimated)
- Study startMay 2008
- Primary completionApr 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic - MITG
- Responsible party
- Sponsor
- Investigators
- DaiWai M Olson, PhD RN, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00734409
- Sponsor's protocol ID
- PRO00002117
- Other IDs
- DUHS parent 3930938
- Acronym
- COST_2
- Status last verified
- Aug 2012
- First submitted
- 3 Jun 2008
- Last updated
- 29 Mar 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Objective and Subjective Sedation Assessment Tools - Second Study
- ClinicalTrials.gov ID
- NCT00734409
- Acronym / sponsor ID
- COST_2 / PRO00002117
- Conditions
- Critical Illness
- Keywords
- Mechanical ventilation, Human, conscious sedation, bispectral index, monitoring, critical care, propofol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Medtronic - MITG
- Study start
- May 2008
- Primary completion
- Apr 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 14 Aug 2008 (estimated)
- Results
- Posted 11 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if the use of a device called the BIS monitor in addition to the Richmond Agitation Sedation Scale will give better assessment of a subject's level of sedation.
Detailed description
Patients in the intensive care unit (ICU) who require a ventilator to help them breathe also require sedation in order to keep them comfortable and prevent injury. The national guidelines for sedation management include a daily interruption of sedation performed once each morning. To determine the amount of sedation needed, the current standard practice is to use a system called the Richmond Agitation-Sedation Scale (RASS). The patient is stimulated by calling their name or by tapping their shoulder until the patient's responses indicate that a satisfactory level of sedation has been achieved.
The purpose of this study is to determine if the use of a device called the BIS monitor in addition to the RASS will give better assessment of a subject's level of sedation. The BIS monitor is a sensor strip taped to the forehead and attached to a device that reads electrical activity from the brain. It is approved by the U.S. Food and Drug Administration (FDA) for monitoring patients under sedation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RASS plus (BIS) | Experimental | Device: Bispectral Index (BIS) MonitorParticipants in this arm will receive sedation assessment with the RASS scale augmented with Bispectral Index (BIS) Monitor |
| RASS only | No intervention | –Participants will receive sedation assessment only using the RASS scale which is the standard of care at our institution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patient in the ICU
- continuous IV sedation with propofol midazolam or dexmedetomidine
- age > 18
- expected to require mechanical ventilation for >=48 hours
Key exclusion criteria (9 listed)
- prisoners
- no available space on forehead
- continuous electroencephalography(EEG) monitoring
- bifrontal brain injury
- barbiturate coma therapy
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 |
|---|---|---|
| Bispectral Index (BIS) MonitorAlso: Richmond agitation sedation scale, neurofunction monitorBIS monitoring in addition to RASS assessments | Device | RASS plus (BIS) |
Primary outcome
Mean Sedative Use
Time frame: Intensive Care Unit (ICU) stay through discharge
The mean amount of propofol used on each patient while the patient was in the ICU and receiving mechanical ventilation.
2 secondary outcomes
Unplanned Self-device Removal Events
Time frame: ICU stay through discharge
Mean Days on Mechanical Ventilation
Time frame: ICU stay- through discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
DaiWai M Olson, PhD RN principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bispectral Index (BIS) Monitor in people with Critical Illness, run by Duke University 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 4 inclusion and 9 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: finished, as of the sponsor's last update on 29 Mar 2013. 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?
Yes. Results are posted in the registry (first posted 11 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Sedative Use (time frame: Intensive Care Unit (ICU) stay through discharge). 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 29 Mar 2013.