Brain DamageNCT04846738
Transcranial Doppler and Quantitative Pupillometry as Neurological Prognostic Factors in Brain Damaged Patients Admitted to Intensive Care Unit
An observational study of Brain Damage, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Transcranial Doppler is performed daily in Intensive Care Unit in brain damaged patients. For a few years now, the measurement of the photomotor reflex by quantitative Pupillometry has been routinely performed in Intensive Care Units. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Damage
- What is being tested?
- Transcranial Doppler and Pupillometry.
- Type of treatment
- Medical device
- How many people
- 73 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2021to 14 Aug 2022
- Phase
- Observational
- 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
Study population: All brain damaged patients (stroke or head trauma), admitted to Intensive Care Unit since December 1, 2020
Who may be able to join
- All brain damaged patients (stroke or head trauma)
- Admitted to Intensive Care Unit since December 1, 2020
Who cannot join
- Refusal by the patient or his/her legal representative.
- Benefiting from legal protection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Interest of Transcranial Doppler and Quantitative Pupillometry as Neurological Prognostic Factors at 12 Months in Brain Damaged Patients (Stroke or Head Trauma) Admitted to Intensive Care Unit
Transcranial Doppler is performed daily in Intensive Care Unit in brain damaged patients. For a few years now, the measurement of the photomotor reflex by quantitative Pupillometry has been routinely performed in Intensive Care Units. The objective of this work is to see if Transcranial Doppler recorded parameters and Pupillary parameters are correlated to the neurological prognosis evaluated at 9 months by the Modified Rankin Score (mRS) and the Glasgow Outcome Scale Extended (GOS-E).
- Conditions
- Brain Damage
- Being tested
- Transcranial Doppler, Pupillometry.
- Keywords
- Brain injury, Transcranial Doppler, Quantitative Pupillometry,, neurological prognosis, modified Rankin Score (mRS), Glasgow Outcome Scale Extended (GOS-E)
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial DopplerDevice
This device measures Mean Systolic Velocity (VMS), Tele-Diastolic Velocity (TDV) and Pulsatility Index (PI),
Pupillometry.Device
Also called AlgiScan
This device measures the photomotor reflex (basic pupil diameter, percentage of variation, latent and slope of the standard photomotor reflex)
| Study group | Role | What they receive |
|---|---|---|
| brain damaged patients | All major brain damaged patients (stroke or head trauma) admitted to reanimation will be included.
In the usual practice, they have a Transcranial Doppler and the measurement of the photomotor reflex by quantitative Pupillometry.
It is planned to collect the simultaneous values of the different parameters during 2,000 measurements.
The data will be collected retrospectively from 01/12/2020, and prospectively from 01/04/2021. Receives: Device: Transcranial Doppler; Device: Pupillometry. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin Score (mRS) (0-5)
Modified Rankin Score (mRS) measures the degree of disability following a stroke in a patient (level 0 for patients with no symptoms to level 5 for patients with major disability and total dependency)..
Measured: Year: 1
Glasgow Outcome Scale Extended (GOS-E) (1-8)
Glasgow Outcome Scale Extended (GOS-E) measure the impact of brain injured (minimum at 1 (Dead) and maximum at 8 (Upper Good Recovery).
Measured: Year: 1
Secondary outcomes (14)
Mean Systolic Velocity (VMS)
Measured by Transcranial Doppler right and left.
Measured: At inclusion
Intra-Cranial Pressure (ICP)
Collect on medical file.
Measured: At inclusion
Pulsatility Index (PI)
Measured by Transcranial Doppler right and left.
Measured: At inclusion
Tele-Diastolic Velocity (TDV)
Measured by Transcranial Doppler right and left.
Measured: At inclusion
Basic pupil diameter
Measured by Pupillometry right and left
Measured: At inclusion
Percentage of variation of the pupil diameter
Measured by Pupillometry right and left
Measured: At inclusion
Latent and slope of the standard photomotor reflex
Measured by Pupillometry right and left
Measured: At inclusion
Tissue Partial Oxygen Pressure (PtiO2)
Collect on medical file.
Measured: At inclusion
Bispectral Index (BIS)
Collect on medical file. BIS is a reflection of the depth of hypnosis
Measured: At inclusion
Richmond Agitation-Sedation Scale (RASS)
Richmond Agitation-Sedation Scale (RASS) is a symmetrical rating, with positive values for agitation and negative values for the level of consciousness around a point 0 corresponding to a calm and awake patient.
Collect on medical file.
Measured: At inclusion
Heart rate
Collect on medical file.
Measured: At inclusion
Blood pressure
Collect on medical file.
Measured: At inclusion
Natremia (mmol/l)
Collect on medical file.
Measured: At inclusion
Glycemia (mmol/l)
Collect on medical file.
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start1 Apr 2021
- Primary completion14 Jul 2021
- Study completion14 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain DamageStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David CHARIER, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04846738
- Sponsor's protocol ID
- IRBN282021/CHUSTE
- Status last verified
- Apr 2023
- First submitted
- 13 Apr 2021
- Last updated
- 1 May 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Interest of Transcranial Doppler and Quantitative Pupillometry as Neurological Prognostic Factors at 12 Months in Brain Damaged Patients (Stroke or Head Trauma) Admitted to Intensive Care Unit
- ClinicalTrials.gov ID
- NCT04846738
- Acronym / sponsor ID
- IRBN282021/CHUSTE
- Conditions
- Brain Damage
- Keywords
- Brain injury, Transcranial Doppler, Quantitative Pupillometry,, neurological prognosis, modified Rankin Score (mRS), Glasgow Outcome Scale Extended (GOS-E)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 14 Jul 2021 (actual)
- Study completion
- 14 Aug 2022 (actual)
- First posted
- 15 Apr 2021 (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.
Transcranial Doppler is performed daily in Intensive Care Unit in brain damaged patients. For a few years now, the measurement of the photomotor reflex by quantitative Pupillometry has been routinely performed in Intensive Care Units. The objective of this work is to see if Transcranial Doppler recorded parameters and Pupillary parameters are correlated to the neurological prognosis evaluated at 9 months by the Modified Rankin Score (mRS) and the Glasgow Outcome Scale Extended (GOS-E).
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| brain damaged patients | – | Device: Transcranial Doppler, Device: Pupillometry.All major brain damaged patients (stroke or head trauma) admitted to reanimation will be included. In the usual practice, they have a Transcranial Doppler and the measurement of the photomotor reflex by quantitative Pupillometry. It is planned to collect the simultaneous values of the different parameters during 2,000 measurements. The data will be collected retrospectively from 01/12/2020, and prospectively from 01/04/2021. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All brain damaged patients (stroke or head trauma), admitted to Intensive Care Unit since December 1, 2020
Key inclusion criteria (2 listed)
- All brain damaged patients (stroke or head trauma)
- Admitted to Intensive Care Unit since December 1, 2020
Key exclusion criteria (2 listed)
- Refusal by the patient or his/her legal representative.
- Benefiting from legal protection
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 |
|---|---|---|
| Transcranial DopplerThis device measures Mean Systolic Velocity (VMS), Tele-Diastolic Velocity (TDV) and Pulsatility Index (PI), | Device | brain damaged patients |
| Pupillometry.Also: AlgiScanThis device measures the photomotor reflex (basic pupil diameter, percentage of variation, latent and slope of the standard photomotor reflex) | Device | brain damaged patients |
Primary outcome
Modified Rankin Score (mRS) (0-5)
Time frame: Year: 1
Modified Rankin Score (mRS) measures the degree of disability following a stroke in a patient (level 0 for patients with no symptoms to level 5 for patients with major disability and total dependency)..
Glasgow Outcome Scale Extended (GOS-E) (1-8)
Time frame: Year: 1
Glasgow Outcome Scale Extended (GOS-E) measure the impact of brain injured (minimum at 1 (Dead) and maximum at 8 (Upper Good Recovery).
14 secondary outcomes
Mean Systolic Velocity (VMS)
Time frame: At inclusion
Intra-Cranial Pressure (ICP)
Time frame: At inclusion
Pulsatility Index (PI)
Time frame: At inclusion
Tele-Diastolic Velocity (TDV)
Time frame: At inclusion
Basic pupil diameter
Time frame: At inclusion
Percentage of variation of the pupil diameter
Time frame: At inclusion
Latent and slope of the standard photomotor reflex
Time frame: At inclusion
Tissue Partial Oxygen Pressure (PtiO2)
Time frame: At inclusion
Bispectral Index (BIS)
Time frame: At inclusion
Richmond Agitation-Sedation Scale (RASS)
Time frame: At inclusion
Heart rate
Time frame: At inclusion
Blood pressure
Time frame: At inclusion
Natremia (mmol/l)
Time frame: At inclusion
Glycemia (mmol/l)
Time frame: At inclusion
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 1 May 2023.
- 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.
David CHARIER, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Damage, run by Centre Hospitalier Universitaire de Saint Etienne 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 2 inclusion and 2 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 1 May 2023. 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?
Modified Rankin Score (mRS) (0-5) (time frame: Year: 1). The study lists 2 primary outcomes in all. 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 1 May 2023.