RASS-scorePSIWAVNCT05587803
Comparison of 2 Depth of Sedation Indices in the Intensive Care Unit
A study testing Neurowave and Sedline indices in view in people with RASS-score and Deep Sedation, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
In the intensive care unit of the Free University hospital of Brussels, sedated patients are standardly monitored with the Masimo SEDline device to see how deeply a patient is asleep. During this study we want to attach 1 extra device to 30 sedated patients, lying in the intensive care unit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- RASS-score, Deep Sedation, Post-cardiac Surgery
- What is being tested?
- Neurowave and Sedline indices in view
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 9 May 2022to 1 Jun 2023
- 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
- Sedated patients hospitalized in ICU of the University Hospital of Brussels
- Patients who are monitored with the SEDline/Masimo monitor
- Patients who receive Remifentanil at a maximum concentration of 0,2 μg/kg/min and propofol with a concentration between 0,5-4,0 mg/kg/h
- Age above 18 years
Who cannot join
- Patients with facial trauma
- Pregnant patients
- Patients who received muscle re-laxants
- Patients in prone position
- Lack of informed consent from the family
- Patients who are hemodynamically unstable
- Patients with neurotrauma or every other neurologic disorder
- Patients post neurosurgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of NeuroSense/NeuroWave and Sedline/Masimo Indices for Measuring Depth of Sedation in the Intensive Care Unit.
In the intensive care unit of the Free University hospital of Brussels, sedated patients are standardly monitored with the Masimo SEDline device to see how deeply a patient is asleep. During this study we want to attach 1 extra device to 30 sedated patients, lying in the intensive care unit. This device, called the NeuroSENSE brain monitor from Neurowave systems, uses a different scale to indicate the ideal depth of sedation. In total, both devices will be hung on a patient for 2 times 35 minutes. At minute 33, a RASS score will be determined in each patient. This score will be determined by talking to the patient or administering a pain stimulus. Based on the reaction of the patient an estimation can be made how deeply a patient is sleeping. Our goal is to find out which device correlates best with the effective clinical state of the patient.
Read the detailed description
Adequate sedation level is important for patient comfort and safety. As under- and oversedation are common several devices are used that measure the Depth of Anesthesia (DoA). Each device uses its proprietary algorithm to calculate a depth of anesthesia index and each index has its own optimal range. The optimal range for the NeuroSense monitor (NeuroWave Systems inc., Cleveland, OH, USA) is between 40 and 60, while the optimal range for the SEDline monitor (Masimo Corporation; Irvine, CA, USA) is between 25 and 50. When the device indicates a value within these limits, the patient is optimally anesthetized for a surgical procedure. In this study, 30 patients will be monitored simultaneously by both the Neurowave and SedLine devices. The study will determine which device is the most accurate and therefore the most ideal for use in the ICU.
- Conditions
- RASS-score, Deep Sedation, Post-cardiac Surgery
- Being tested
- Neurowave and Sedline indices in view
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurowave and Sedline indices in viewDevice
3 additional electrodes are attached on the patients forehead. After electrode placement, the indices of both the SEDLINE device and the NEUROWAVE device are noted every 5 seconds for 1 minute
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | This arm consists of all the patients that fulfill the inclusion and exclusion-criteria and are therefore suitable for the study. The Neurowave brain monitor is attached on the patients forehead and the study starts. At that moment the included patients are monitored by the Masimo/Sedline en the Neurosense/Neurowave monitor. Receives: Device: Neurowave and Sedline indices in view |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the depth of sedation indices per assigned RASS score using the prediction probability
The main objective of the study is to compare the DoA indices of the NeuroSense/NeuroWave monitor and the SEDline/Masimo monitor in sedated patients in ICU. Both values are then correlated with the patient's clinical sedation level by assigning a RASS score to the patient each time. The RASS score stands for Richmond Agitation Sedation Scale and ranges from -5 to +4. A score of -5 stands for a patient who is unresponsive to any stimuli whereas a score of +4 means a highly combative patient. To determine which device correlates best with the clinic, predictive probability will be used. The prediction probability is a value between 0 and 1. A score of 1 corresponds to a correct classification of the DoA in each case. A value of 0 corresponds to a discordance between the clinic and the index value. The device whose predictive probability is closest to 1 correlates best with the clinic and will likely be the best device to use.
Measured: 33 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start9 May 2022
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RASS-scoreStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Poelaert, MD,PhD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05587803
- Sponsor's protocol ID
- 22056PSIWAV
- Acronym
- PSIWAV
- Status last verified
- May 2023
- First submitted
- 16 Sep 2022
- Last updated
- 9 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of NeuroSense/NeuroWave and Sedline/Masimo Indices for Measuring Depth of Sedation in the Intensive Care Unit.
- ClinicalTrials.gov ID
- NCT05587803
- Acronym / sponsor ID
- PSIWAV / 22056PSIWAV
- Conditions
- RASS-score, Deep Sedation, Post-cardiac Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 9 May 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 20 Oct 2022 (actual)
- 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.
In the intensive care unit of the Free University hospital of Brussels, sedated patients are standardly monitored with the Masimo SEDline device to see how deeply a patient is asleep. During this study we want to attach 1 extra device to 30 sedated patients, lying in the intensive care unit. This device, called the NeuroSENSE brain monitor from Neurowave systems, uses a different scale to indicate the ideal depth of sedation. In total, both devices will be hung on a patient for 2 times 35 minutes. At minute 33, a RASS score will be determined in each patient. This score will be determined by talking to the patient or administering a pain stimulus. Based on the reaction of the patient an estimation can be made how deeply a patient is sleeping. Our goal is to find out which device correlates best with the effective clinical state of the patient.
Detailed description
Adequate sedation level is important for patient comfort and safety. As under- and oversedation are common several devices are used that measure the Depth of Anesthesia (DoA). Each device uses its proprietary algorithm to calculate a depth of anesthesia index and each index has its own optimal range. The optimal range for the NeuroSense monitor (NeuroWave Systems inc., Cleveland, OH, USA) is between 40 and 60, while the optimal range for the SEDline monitor (Masimo Corporation; Irvine, CA, USA) is between 25 and 50. When the device indicates a value within these limits, the patient is optimally anesthetized for a surgical procedure. In this study, 30 patients will be monitored simultaneously by both the Neurowave and SedLine devices. The study will determine which device is the most accurate and therefore the most ideal for use in the ICU.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Device: Neurowave and Sedline indices in viewThis arm consists of all the patients that fulfill the inclusion and exclusion-criteria and are therefore suitable for the study. The Neurowave brain monitor is attached on the patients forehead and the study starts. At that moment the included patients are monitored by the Masimo/Sedline en the Neurosense/Neurowave monitor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Sedated patients hospitalized in ICU of the University Hospital of Brussels
- Patients who are monitored with the SEDline/Masimo monitor
- Patients who receive Remifentanil at a maximum concentration of 0,2 μg/kg/min and propofol with a concentration between 0,5-4,0 mg/kg/h
- Age above 18 years
Key exclusion criteria (8 listed)
- Patients with facial trauma
- Pregnant patients
- Patients who received muscle re-laxants
- Patients in prone position
- Lack of informed consent from the family
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 |
|---|---|---|
| Neurowave and Sedline indices in view3 additional electrodes are attached on the patients forehead. After electrode placement, the indices of both the SEDLINE device and the NEUROWAVE device are noted every 5 seconds for 1 minute | Device | study group |
Primary outcome
Comparison of the depth of sedation indices per assigned RASS score using the prediction probability
Time frame: 33 minutes
The main objective of the study is to compare the DoA indices of the NeuroSense/NeuroWave monitor and the SEDline/Masimo monitor in sedated patients in ICU. Both values are then correlated with the patient's clinical sedation level by assigning a RASS score to the patient each time. The RASS score stands for Richmond Agitation Sedation Scale and ranges from -5 to +4. A score of -5 stands for a patient who is unresponsive to any stimuli whereas a score of +4 means a highly combative patient. To determine which device correlates best with the clinic, predictive probability will be used. The prediction probability is a value between 0 and 1. A score of 1 corresponds to a correct classification of the DoA in each case. A value of 0 corresponds to a discordance between the clinic and the index value. The device whose predictive probability is closest to 1 correlates best with the clinic and will likely be the best device to use.
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 9 Feb 2024.
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.
Jan Poelaert, MD,PhD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurowave and Sedline indices in view in people with RASS-score and Deep Sedation, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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 8 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 9 Feb 2024. 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 Belgium. 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?
Comparison of the depth of sedation indices per assigned RASS score using the prediction probability (time frame: 33 minutes). 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 9 Feb 2024.