Brain InjuryPhase 4COSTNCT00538369
Combining Observational and Physiologic Sedation Assessment Tools
A Phase 4 study testing Ramsay Scale and Bispectral index monitor in people with Brain Injury, run by Duke University at 1 site in United States.
Trial summary
When a physiologic tool to measure the patient's hypnotic state is added to current practice tools is there a decrease in the amount of drug the patient receives. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Injury
- What is being tested?
- Ramsay Scale and Bispectral index monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Sep 2007
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult
- admitted with a neurological or neurosurgical diagnosis
- intubated and on mechanical ventilatory support
- receiving continuous sedation with propofol
- Glasgow Coma Score <12
Who cannot join
- bifrontal brain injury
- status epilepticus
- barbiturate coma therapy
- continuous benzodiazepine administration
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
When a physiologic tool to measure the patient's hypnotic state is added to current practice tools is there a decrease in the amount of drug the patient receives.
Read the detailed description
The purposes of this study were to examine the effect of combining a physiologic measure of consciousness (BIS) with observational assessment of sedation (Ramsay) on infused sedation drug volumes, undersedation events, and the recovery time to arouse from sedation, in a group of neurocritically ill patients. During a 12-hour data collection period, patients received sedation assessment and management with either the current standard of care (sedation assessment with the Ramsay scale), or the standard of care plus the addition of physiologic data from BIS monitoring. Planned research questions explored how BIS monitoring impacts short-term sedation-related outcomes.
Research Questions
- Is there less sedation drug use for patients when nurses monitor sedation with BIS augmentation of Ramsay than when nurses monitor patients with Ramsay alone?
- Is sedation assessment augmented by BIS use associated with a decreased time to wake-up (recovery time) when nurses are instructed to interrupt sedation and obtain a neurologic examination, compared to use of Ramsay alone?
- Are there differences in the number of events associated with undersedation (e.g., self-extubation) for patients assigned to BIS augmentation compared to patients assigned to Ramsay alone?
- Conditions
- Brain Injury
- Being tested
- Ramsay Scale, Bispectral index monitor
- Keywords
- Nursing, critical care, sedation assessment, Bispectral index
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ramsay ScaleOther
Also called Ramsay sedation scale
While receiving sedation, subjects will be monitored with the Ramsay scale
Bispectral index monitorDevice
Also called BIS
While receiving sedation, subjects will receive BIS monitoring
| Study group | Role | What they receive |
|---|---|---|
| standard-of-care | Active comparator | The standard-of-care group will receive sedation assessment and monitoring with the Ramsay scale, which is the accepted tool at this university Receives: Other: Ramsay Scale |
| standard + BIS | Experimental | Subjects in the standard-of-care + BIS group will receive sedation assessment and monitoring using the Ramsay scale and values from the bispectral index (BIS) monitor. Receives: Other: Ramsay Scale; Device: Bispectral index monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
How much sedative was infused
Measured: length of stay
Secondary outcomes (2)
How quickly the subject recovered from sedation
Measured: once
The number of undersedation events
Measured: length of stay in ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2007 (estimated)
- Study startNov 2006
- Study completionSep 2007
Why it stopped: Lack of equipoise
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain InjuryStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, Medtronic - MITG
- Responsible party
- Sponsor
- Investigators
- DaiWai M Olson, PhD RN CCRN, Principal investigator, Duke UniversitySuzanne M Thoyre, PhD RN, Study chair, University of North Carolina, Chapel HillCarmelo Graffagnino, MD FRCPC, Study director, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00538369
- Sponsor's protocol ID
- Pro00008519
- Other IDs
- 8771-06 - 8RO
- Acronym
- COST
- Status last verified
- Oct 2007
- First submitted
- 1 Oct 2007
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ramsay MA, Savege TM, Simpson BR, Goodwin R. Controlled sedation with alphaxalone-alphadolone. Br Med J. 1974 Jun 22;2(5920):656-9. doi: 10.1136/bmj.2.5920.656.
PubMed 4835444
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Observational and Physiologic Sedation Assessment Tools
- ClinicalTrials.gov ID
- NCT00538369
- Acronym / sponsor ID
- COST / Pro00008519
- Conditions
- Brain Injury
- Keywords
- Nursing, critical care, sedation assessment, Bispectral index
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of equipoise
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- University of North Carolina, Medtronic - MITG
- Study start
- Nov 2006
- Study completion
- Sep 2007 (actual)
- First posted
- 2 Oct 2007 (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.
When a physiologic tool to measure the patient's hypnotic state is added to current practice tools is there a decrease in the amount of drug the patient receives.
Detailed description
The purposes of this study were to examine the effect of combining a physiologic measure of consciousness (BIS) with observational assessment of sedation (Ramsay) on infused sedation drug volumes, undersedation events, and the recovery time to arouse from sedation, in a group of neurocritically ill patients. During a 12-hour data collection period, patients received sedation assessment and management with either the current standard of care (sedation assessment with the Ramsay scale), or the standard of care plus the addition of physiologic data from BIS monitoring. Planned research questions explored how BIS monitoring impacts short-term sedation-related outcomes.
Research Questions
- Is there less sedation drug use for patients when nurses monitor sedation with BIS augmentation of Ramsay than when nurses monitor patients with Ramsay alone?
- Is sedation assessment augmented by BIS use associated with a decreased time to wake-up (recovery time) when nurses are instructed to interrupt sedation and obtain a neurologic examination, compared to use of Ramsay alone?
- Are there differences in the number of events associated with undersedation (e.g., self-extubation) for patients assigned to BIS augmentation compared to patients assigned to Ramsay alone?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard-of-care | Active comparator | Other: Ramsay ScaleThe standard-of-care group will receive sedation assessment and monitoring with the Ramsay scale, which is the accepted tool at this university |
| standard + BIS | Experimental | Other: Ramsay Scale, Device: Bispectral index monitorSubjects in the standard-of-care + BIS group will receive sedation assessment and monitoring using the Ramsay scale and values from the bispectral index (BIS) monitor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult
- admitted with a neurological or neurosurgical diagnosis
- intubated and on mechanical ventilatory support
- receiving continuous sedation with propofol
- Glasgow Coma Score <12
Key exclusion criteria (4 listed)
- bifrontal brain injury
- status epilepticus
- barbiturate coma therapy
- continuous benzodiazepine administration
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 |
|---|---|---|
| Ramsay ScaleAlso: Ramsay sedation scaleWhile receiving sedation, subjects will be monitored with the Ramsay scale | Other | standard + BIS, standard-of-care |
| Bispectral index monitorAlso: BISWhile receiving sedation, subjects will receive BIS monitoring | Device | standard + BIS |
Primary outcome
How much sedative was infused
Time frame: length of stay
2 secondary outcomes
How quickly the subject recovered from sedation
Time frame: once
The number of undersedation events
Time frame: length of stay in ICU
Results and safety
The study was stopped early (reason given: Lack of equipoise). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.
- Background: PubMed 4835444Ramsay MA, Savege TM, Simpson BR, Goodwin R. Controlled sedation with alphaxalone-alphadolone. Br Med J. 1974 Jun 22;2(5920):656-9. doi: 10.1136/bmj.2.5920.656.
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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 CCRN principal investigator
Duke University
Suzanne M Thoyre, PhD RN study chair
University of North Carolina, Chapel Hill
Carmelo Graffagnino, MD FRCPC study director
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ramsay Scale and Bispectral index monitor in people with Brain Injury, 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 5 inclusion and 4 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 14 Oct 2015. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of equipoise). 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?
How much sedative was infused (time frame: length of stay). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00538369, which also lists 1 linked publication.
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 14 Oct 2015.