Intensive CareNCT01997931
The Impact of Bispectral Index Monitoring on Sedation Administration in Mechanically Ventilated Patients
A study testing Bispectral Index Sedation monitor in people with Intensive Care and Mechanically Ventilated Patients, run by Bayside Health at 1 site in Australia.
Trial summary
This prospective randomised controlled trial was designed to assess the effectiveness of the Bispectral Index Sedation (BIS) monitor in supporting clinical, sedation management decisions in mechanically ventilated ICU patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care, Mechanically Ventilated Patients, Sedated Patients
- What is being tested?
- Bispectral Index Sedation monitor
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteAustralia
- Study dates
- Sep 2004to Jul 2005
- Phase
- Interventional
- 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
- Intubated and ventilated for at least 24 hours
- Sedated on morphine and midazelam infusions
Who cannot join
- Intracranial injury
- Status epilepticus
- Facial Burns
Trial locations and contacts
1 site in 1 country.
About this study
This prospective randomised controlled trial was designed to assess the effectiveness of the Bispectral Index Sedation (BIS) monitor in supporting clinical, sedation management decisions in mechanically ventilated ICU patients.
The primary hypothesis for the study is that patients with Bispectral Index Sedation (BIS) monitoring will receive less sedation then those receiving standard sedation management.
The secondary hypotheses are:
- Patients with BIS have fewer ventilation days than those receiving standard sedation management.
- Level of sedation administered will differ according to the critical care experience and qualification of the nurse.
Read the detailed description
Patients in intensive care units (ICUs) frequently require sedatives and analgesics as part of therapy. Assessing the appropriate dose of sedative and analgesic drugs can be difficult due to the severity of the patient's illness, inability of the patient to communicate, multiple procedures and transports for investigations and the subjectivity of clinical sedation assessment tools. Poorly assessed and managed levels of sedation can result in over sedation, extended ventilation time and a potentially extended ICU stay.
The BIS monitor is derived from the electroencephalogram and provides a numeric value that represents a measure of cerebral activity. Such an objective measure of the patient's level of sedation may provide a useful tool that will enable nurses to titrate sedation more accurately in an attempt to provide the optimal level of sedation for all ICU patients.
The study will be conducted in the Intensive Care Unit at the Alfred Hospital. This study is designed as a prospective randomised control trial with parallel design. This means that participants' will be randomly allocated into either one of two groups - an intervention or control group. Participant's randomised to the intervention group will receive BIS monitoring. The control group will receive standard ICU sedation assessment and management.
To determine if BIS monitoring is useful in ICU, information will be collected by auditing patient charts and determining the average amounts of sedation medication for each nursing shift. In addition, the years of critical care experience and critical care qualification will be recorded for each nurse managing patients recruited to the study.
- Being tested
- Bispectral Index Sedation monitor
- Keywords
- bispectral index, sedation, intensive care, mechanical ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bispectral Index Sedation monitorDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimised sedation management for patients through the use of BIS monitoring.
Secondary outcomes (2)
Reduction in mechanical ventilation time.
Reduced length of stay in the intensive care unit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2013 (estimated)
- Study startSep 2004
- Primary completionJun 2005
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive CareStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- Bayside Health
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Cindy A Weatherburn, Principal investigator, The Alfred
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01997931
- Sponsor's protocol ID
- 111/04
- Status last verified
- Nov 2013
- First submitted
- 9 Sep 2005
- Last updated
- 28 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Bispectral Index Monitoring on Sedation Administration in Mechanically Ventilated Patients
- ClinicalTrials.gov ID
- NCT01997931
- Acronym / sponsor ID
- 111/04
- Keywords
- bispectral index, sedation, intensive care, mechanical ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- Bayside HealthOther government
- Study start
- Sep 2004
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jul 2005 (actual)
- First posted
- 28 Nov 2013 (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.
This prospective randomised controlled trial was designed to assess the effectiveness of the Bispectral Index Sedation (BIS) monitor in supporting clinical, sedation management decisions in mechanically ventilated ICU patients.
The primary hypothesis for the study is that patients with Bispectral Index Sedation (BIS) monitoring will receive less sedation then those receiving standard sedation management.
The secondary hypotheses are:
- Patients with BIS have fewer ventilation days than those receiving standard sedation management.
- Level of sedation administered will differ according to the critical care experience and qualification of the nurse.
Detailed description
Patients in intensive care units (ICUs) frequently require sedatives and analgesics as part of therapy. Assessing the appropriate dose of sedative and analgesic drugs can be difficult due to the severity of the patient's illness, inability of the patient to communicate, multiple procedures and transports for investigations and the subjectivity of clinical sedation assessment tools. Poorly assessed and managed levels of sedation can result in over sedation, extended ventilation time and a potentially extended ICU stay.
The BIS monitor is derived from the electroencephalogram and provides a numeric value that represents a measure of cerebral activity. Such an objective measure of the patient's level of sedation may provide a useful tool that will enable nurses to titrate sedation more accurately in an attempt to provide the optimal level of sedation for all ICU patients.
The study will be conducted in the Intensive Care Unit at the Alfred Hospital. This study is designed as a prospective randomised control trial with parallel design. This means that participants' will be randomly allocated into either one of two groups - an intervention or control group. Participant's randomised to the intervention group will receive BIS monitoring. The control group will receive standard ICU sedation assessment and management.
To determine if BIS monitoring is useful in ICU, information will be collected by auditing patient charts and determining the average amounts of sedation medication for each nursing shift. In addition, the years of critical care experience and critical care qualification will be recorded for each nurse managing patients recruited to the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Intubated and ventilated for at least 24 hours
- Sedated on morphine and midazelam infusions
Key exclusion criteria (3 listed)
- Intracranial injury
- Status epilepticus
- Facial Burns
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 Sedation monitor | Device | – |
Primary outcome
Optimised sedation management for patients through the use of BIS monitoring.
2 secondary outcomes
Reduction in mechanical ventilation time.
Reduced length of stay in the intensive care unit.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2013.
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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.
Cindy A Weatherburn principal investigator
The Alfred
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 Sedation monitor in people with Intensive Care and Mechanically Ventilated Patients, run by Bayside Health at 1 site in Australia.
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 2 inclusion and 3 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 28 Nov 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 Australia. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Optimised sedation management for patients through the use of BIS monitoring.. 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 Nov 2013.