Sedated ICU PatientsNCT01361230
IMPROVE Critical Care Study (Pilot)
A study testing "Sedation Trial Monitor" is the name of the device used. in people with Sedated ICU Patients, run by GE Healthcare at 1 site in United Kingdom.
Trial summary
The Pilot Clinical Investigation planned is a prospective, unblinded randomized pilot trial comparing sedation management using a protocol based on responsiveness with standard sedation management. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sedated ICU Patients
- What is being tested?
- "Sedation Trial Monitor" is the name of the device used.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2009to May 2011
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients mechanically ventilated via an endotracheal tube and receiving intravenous sedation with a hypnotic agent (midazolam or other benzodiazepine) or propofol by continuous infusion.
Who cannot join
- Primary intracerebral disorder (includes cardiac arrest with probable hypoxic brain injury; intrac-ranial haemorrhage; head injury causing reduced conscious level prior to intubation)
- Patient who is already awake at the time of enrolment defined as RASS ³ -1
- Age <16 years
- Patient not expected to survive the next 24 hours
- Patient receiving long term ventilation prior to ICU admission
- Patient with a long term tracheostomy prior to ICU admission
Show all 12Show fewer
- Patient transferred sedated and mechanically ventilated from another ICU unless recruitment is possible within 24 hours of first ICU admission
- Patient receiving continuous neuromuscular blocking agent at the time of screening for enrolment
- Previously enrolled in the trial during a separate ICU admission during this hospital stay
- Status epilepticus
- Confirmed meningitis or encephalitis at the time of screening for enrolment
- Chronic neurological disease interfering with normal neuromuscular function, e.g. motor neurone disease, Guillain-Barre syndrome or inherited neuromyopathies
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Infirmary Edinburgh (Great Britain) ward 118
Edinburgh, Scotland, EH16 4SA
About this study
Official title: PILOT STUDY: A Randomized Controlled Trial of Intensive Care Management of Sedation Using Patient Responsiveness in Critical Care IMPROVE Critical Care Study Pilot
The Pilot Clinical Investigation planned is a prospective, unblinded randomized pilot trial comparing sedation management using a protocol based on responsiveness with standard sedation management. The hypothesis is that responsiveness will improve a range of patient-based and economic outcomes, including the duration of mechanical ventilation and duration of coma in the ICU. The purpose of the pilot study is to gather information for designing a full study that might show the validity of the outcome hypothesis.
- Conditions
- Sedated ICU Patients
- Being tested
- "Sedation Trial Monitor" is the name of the device used.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Sedation Trial Monitor" is the name of the device used.Device
This is a pilot unblinded randomised controlled trial comparing sedation management using responsiveness (new intervention) with usual care (control group).
| Study group | Role | What they receive |
|---|---|---|
| Protocol | Experimental | Using sedation monitoring and protocol Receives: Device: "Sedation Trial Monitor" is the name of the device used. |
| Control | No intervention | Standard practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of time spent with low responsiveness (red colour code) during the first 48 hours in the ICU
The main purpose in the statistical analysis is not to test the statistical significance of the differences but to provide descriptive statistics for the full outcome study plan.
Measured: 8 month period
Secondary outcomes (1)
Proportion of time spent with RASS score -4/-5 during the first 48 hours in the ICU.
The main purpose in the statistical analysis is not to test the statistical significance of the differences but to provide descriptive statistics for the full outcome study plan.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2011 (estimated)
- Study startDec 2009
- Primary completionSep 2010
- Study completionMay 2011
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 Sedated ICU PatientsStudies of the same condition, open and under way.
- More trials run by GE HealthcareThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Kimmo Uutela, PhD, Study director, GEHCTimothy Walsh, PhD MD, Principal investigator, Royal Infirmary of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01361230
- Sponsor's protocol ID
- DOC0676170
- Status last verified
- May 2011
- First submitted
- 19 Apr 2010
- Last updated
- 26 May 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Kaila M, Everingham K, Lapinlampi P, Peltola P, Sarkela MO, Uutela K, Walsh TS. A randomized controlled proof-of-concept trial of early sedation management using Responsiveness Index monitoring in mechanically ventilated critically ill patients. Crit Care. 2015 Sep 11;19(1):333. doi: 10.1186/s13054-015-1043-1.
PubMed 26370687
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PILOT STUDY: A Randomized Controlled Trial of Intensive Care Management of Sedation Using Patient Responsiveness in Critical Care IMPROVE Critical Care Study Pilot
- ClinicalTrials.gov ID
- NCT01361230
- Acronym / sponsor ID
- DOC0676170
- Conditions
- Sedated ICU Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 26 May 2011 (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.
The Pilot Clinical Investigation planned is a prospective, unblinded randomized pilot trial comparing sedation management using a protocol based on responsiveness with standard sedation management. The hypothesis is that responsiveness will improve a range of patient-based and economic outcomes, including the duration of mechanical ventilation and duration of coma in the ICU. The purpose of the pilot study is to gather information for designing a full study that might show the validity of the outcome hypothesis.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Protocol | Experimental | Device: "Sedation Trial Monitor" is the name of the device used.Using sedation monitoring and protocol |
| Control | No intervention | –Standard practice |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients mechanically ventilated via an endotracheal tube and receiving intravenous sedation with a hypnotic agent (midazolam or other benzodiazepine) or propofol by continuous infusion.
Key exclusion criteria (12 listed)
- Primary intracerebral disorder (includes cardiac arrest with probable hypoxic brain injury; intrac-ranial haemorrhage; head injury causing reduced conscious level prior to intubation)
- Patient who is already awake at the time of enrolment defined as RASS ³ -1
- Age <16 years
- Patient not expected to survive the next 24 hours
- Patient receiving long term ventilation prior to ICU admission
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 |
|---|---|---|
| "Sedation Trial Monitor" is the name of the device used.This is a pilot unblinded randomised controlled trial comparing sedation management using responsiveness (new intervention) with usual care (control group). | Device | Protocol |
Primary outcome
Proportion of time spent with low responsiveness (red colour code) during the first 48 hours in the ICU
Time frame: 8 month period
The main purpose in the statistical analysis is not to test the statistical significance of the differences but to provide descriptive statistics for the full outcome study plan.
1 secondary outcome
Proportion of time spent with RASS score -4/-5 during the first 48 hours in the ICU.
Time frame: 8 months
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 26 May 2011.
- Derived from this study: PubMed 26370687Kaila M, Everingham K, Lapinlampi P, Peltola P, Sarkela MO, Uutela K, Walsh TS. A randomized controlled proof-of-concept trial of early sedation management using Responsiveness Index monitoring in mechanically ventilated critically ill patients. Crit Care. 2015 Sep 11;19(1):333. doi: 10.1186/s13054-015-1043-1.
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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.
Kimmo Uutela, PhD study director
GEHC
Timothy Walsh, PhD MD principal investigator
Royal Infirmary of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Sedation Trial Monitor" is the name of the device used. in people with Sedated ICU Patients, run by GE Healthcare at 1 site in United Kingdom.
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 12 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 26 May 2011. 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 Kingdom. 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?
Proportion of time spent with low responsiveness (red colour code) during the first 48 hours in the ICU (time frame: 8 month period). 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 NCT01361230, 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 26 May 2011.