Brain MonitorARGOS PlatformNCT06594198
Evaluation of the BRAINDEX Brain Monitor in Cardiac Surgery, Interventional Comparative Study
A study testing Cerebral monitor in people with Brain Monitor and Anaesthesia, run by Braindex at 1 site in France.
Trial summary
The main objective of this study is to show the concordance of the SctO2 values of the ARGOS platform with the standard SctO2 values (comparative study with platform INVOS, Medtronic). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Monitor, Anaesthesia
- What is being tested?
- Cerebral monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 9 Sep 2024to 3 Mar 2025
- 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
- Patient, male or female, over 18 years of age
- Patient scheduled for cardiac surgery with programmed extracorporeal circulation (ECC)
- Patient with no history of scalp injury or or skin diseases
- Patient with an Euroscore 2 of less than 7%.
- Patient affiliated or entitled to a social assurance
Who cannot join
- Weight under 40 kg
- Frontal surface too small to allow application of SctO2, BIS electrodes on the same hemifront
- Patient with severe, unbalanced hypertension
- Measurement of systolic blood pressure (SBP) \> 180 mm Hg and/or diastolic blood pressure (DBP) \> 110 mm Hg
- Patients undergoing emergency surgery
- Patient with chronic renal failure, with glomerular filtration \< 30 ml/min/1.73m², or requiring renal transplantation or requiring renal transplantation
Show all 14Show fewer
- Patient with left ventricular ejection fraction \< 40%
- Patient with a history of ischemic stroke
- Patients with preoperative sepsis
- Patient requiring noradrenaline infusion noradrenaline infusion in the 24 hours prior to surgery
- Patient with preoperative uni or bilateral carotid stenosis bilateral carotid stenosis \> 50%.
- Protected patient: adult under guardianship, curatorship or legal protection, deprived of liberty by judicial or administrative decision.
- Pregnant, parturient or breast-feeding women.
- Patients hospitalized without consent.
Trial locations and contacts
1 site in 1 country.
About this study
The main objective of this study is to show the concordance of the SctO2 values of the ARGOS platform with the standard SctO2 values (comparative study with platform INVOS, Medtronic).
Read the detailed description
SctO2 values from ARGOS and INVOS will be resampled every 30 seconds. The two signals will then be resynchronized and compared on a sample-by-sample basis using a Pearson correlation test. Bias and agreement limits will be assessed using Bland \& Altmann graphs. This test will be carried out for the entire duration of the recording.
- Conditions
- Brain Monitor, Anaesthesia
- Being tested
- Cerebral monitor
- Keywords
- Brain Monitor, ARGOS Platform, SctO2, ANI, bcSEF, EEG bispectral index, Cerebral tissue oxygen saturation, Analgesia Nociception Index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerebral monitorDevice
The study procedure consists of monitoring the values of 3 cerebral parameters: SctO2, bcSEF and ANI measured by the ARGOS sensor. These 3 parameters will be recorded and compared after the intervention with 3 parameters considered as standard: SctO2 measured by the INVOS 7100 cerebral oximeter, the bispectral index (BIS) measured by the BIS monitor and the ANI measured by the MDoloris monitor. These 3 reference parameters are once again usually monitored and recommended for all cardiac surgery.
| Study group | Role | What they receive |
|---|---|---|
| One center and 40 patients | Experimental | Monitor the values of 3 brain parameters: SctO2, bcSEF and ANI measured by the ARGOS sensor. Receives: Device: Cerebral monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of SctO2 values from ARGOS and INVOS
Compare ARGOS and INVOS SctO2 values at different times of interest during the procedure.
Compare ARGOS SctO2 values with invasive central venous and arterial saturation (measured by gasometry) during aortic unclamping.
Compare INVOS SctO2 values with central venous and arterial saturation before, during and after aortic unclamping.
Measured: During the surgical procedure
Secondary outcomes (1)
ANI and Database
For ANI: Compare the ANI values of the ARGOS device with the ANI values of the reference device (ANIv2 monitor, MDoloris Medical Systems).
For the bcSEF: Compare the bcSEF values of the ARGOS and the BIS values at different characteristic times during the procedure.
Build up a database for secondary analysis by continuously recording all data.
Measured: During the surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start9 Sep 2024
- Primary completion9 Sep 2024
- Study completion3 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MonitorStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-centre, prospective, interventional clinical study
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Braindex
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinique de la Sauvegarde
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06594198
- Sponsor's protocol ID
- 2024-A00125
- Acronym
- ARGOS Platform
- Status last verified
- Mar 2025
- First submitted
- 10 Sep 2024
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the BRAINDEX Brain Monitor in Cardiac Surgery, Interventional Comparative Study
- ClinicalTrials.gov ID
- NCT06594198
- Acronym / sponsor ID
- ARGOS Platform / 2024-A00125
- Conditions
- Brain Monitor, Anaesthesia
- Keywords
- Brain Monitor, ARGOS Platform, SctO2, ANI, bcSEF, EEG bispectral index, Cerebral tissue oxygen saturation, Analgesia Nociception Index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- BraindexIndustry (pharma, biotech, devices)
- Collaborators
- Clinique de la Sauvegarde
- Study start
- 9 Sep 2024 (actual)
- Primary completion
- 9 Sep 2024 (actual)
- Study completion
- 3 Mar 2025 (actual)
- First posted
- 19 Sep 2024 (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.
The main objective of this study is to show the concordance of the SctO2 values of the ARGOS platform with the standard SctO2 values (comparative study with platform INVOS, Medtronic).
Detailed description
SctO2 values from ARGOS and INVOS will be resampled every 30 seconds. The two signals will then be resynchronized and compared on a sample-by-sample basis using a Pearson correlation test. Bias and agreement limits will be assessed using Bland \& Altmann graphs. This test will be carried out for the entire duration of the recording.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-centre, prospective, interventional clinical study
| Arm | Type | Receives |
|---|---|---|
| One center and 40 patients | Experimental | Device: Cerebral monitorMonitor the values of 3 brain parameters: SctO2, bcSEF and ANI measured by the ARGOS sensor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient, male or female, over 18 years of age
- Patient scheduled for cardiac surgery with programmed extracorporeal circulation (ECC)
- Patient with no history of scalp injury or or skin diseases
- Patient with an Euroscore 2 of less than 7%.
- Patient affiliated or entitled to a social assurance
Key exclusion criteria (14 listed)
- Weight under 40 kg
- Frontal surface too small to allow application of SctO2, BIS electrodes on the same hemifront
- Patient with severe, unbalanced hypertension
- Measurement of systolic blood pressure (SBP) \> 180 mm Hg and/or diastolic blood pressure (DBP) \> 110 mm Hg
- Patients undergoing emergency surgery
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 |
|---|---|---|
| Cerebral monitorThe study procedure consists of monitoring the values of 3 cerebral parameters: SctO2, bcSEF and ANI measured by the ARGOS sensor. These 3 parameters will be recorded and compared after the intervention with 3 parameters considered as standard: SctO2 measured by the INVOS 7100 cerebral oximeter, the bispectral index (BIS) measured by the BIS monitor and the ANI measured by the MDoloris monitor. These 3 reference parameters are once again usually monitored and recommended for all cardiac surgery. | Device | One center and 40 patients |
Primary outcome
Comparison of SctO2 values from ARGOS and INVOS
Time frame: During the surgical procedure
Compare ARGOS and INVOS SctO2 values at different times of interest during the procedure. Compare ARGOS SctO2 values with invasive central venous and arterial saturation (measured by gasometry) during aortic unclamping. Compare INVOS SctO2 values with central venous and arterial saturation before, during and after aortic unclamping.
1 secondary outcome
ANI and Database
Time frame: During the surgical procedure
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 16 May 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cerebral monitor in people with Brain Monitor and Anaesthesia, run by Braindex at 1 site in France.
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 14 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 16 May 2025. 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 France. 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 SctO2 values from ARGOS and INVOS (time frame: During the surgical procedure). 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 16 May 2025.