HydrocephalusHYDRO-NiPNCT05386303
Quantitative Pupillometry
An observational study of Hydrocephalus and Critical Care, run by Nantes University Hospital at 2 sites in France.
Trial summary
The aim of this study is to assess the diagnostic ability of quantitative pupillometry for the early detection of hydrocephalus during the weaning process of the external ventricular drain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hydrocephalus, Critical Care
- How many people
- 60 participants
- Where
- 2 sitesFrance
- Study dates
- 31 May 2022to 1 Sep 2024
- 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: Adult ICU patients with an EVD included at the beginning of the weaning process
Who may be able to join
- Patient older than 18 years old
- Admitted to the ICU
- With an external ventricular drain
- Consenting to participate (or consent from his/her next of kin, if unable to consent).
Who cannot join
- Patient with pre-existing bilateral pupillary pathology
- Pregnant or breast-feeding patient
- Moribund patient or patient with decision of withholding or withdrawing life-sustaining treatment
- Patient with no health insurance
- Patient under guardianship
Trial locations and contacts
2 sites in 1 country.
France2 sites
Nantes University Hospital
Nant, Loire-Atlantique, 44093
Jérôme DAUVERGNE, IDE, 33 (0) 2.40.16.52.89, jerome.dauvergne@chu-nantes.fr
CHU de Nantes
Nantes, 44093
Jérôme Dauvergne, jerome.dauvergne@chu-nantes.fr
About this study
Official title: Quantitative Pupillometry During External Ventricular Drain Weaning - An Observational Study
The aim of this study is to assess the diagnostic ability of quantitative pupillometry for the early detection of hydrocephalus during the weaning process of the external ventricular drain.
Read the detailed description
Acute hydrocephalus is an emergency often requiring the insertion of an external ventricular drain (EVD). In the aftermath, the patient is transferred to an intensive care unit (ICU) for close monitoring. Ensuring optimal cerebral perfusion through efficient drainage of cerebrospinal fluid while minimizing drainage duration are the objectives of care.
Assessing pupillary light reflex is a key test for the detection of neurological deterioration. For long, this assessment has been grossly performed via a qualitative approach (present/absence of pupillary light reflex). For a more precise assessment, quantitative pupillometry has been proposed. Pupil size and constriction speed in response to a standard light are recorded by an automatic portable and user-friendly device. This device is increasingly used in the ICU, mostly for prognostication after acute brain injury. We hypothesized that quantitative pupillometry parameters may vary when hydrocephalus occurs.
The aim of this study is to assess whether quantitative pupillometry parameters vary when hydrocephalus occurs. The investigators focused on the early detection of hydrocephalus during the EVD weaning process.
- Conditions
- Hydrocephalus, Critical Care
- Keywords
- Pupillometry, External ventricular drain, Weaning, Brain injury, Pupillary reactivity
- Medical subject headings
- Hydrocephalus, Brain Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
NPi (Neurological Pupil index) and EVD (external ventricular drain)occlusion test
NPi will be compared between two groups of patients (constituted a posteriori): success and failure of the EVD occlusion test.
Independently of this study, the EDV occlusion test starts as soon as prescribed by the physician as a prerequisite before its withdrawal.
Failing an occlusion test is defined by the need for reopening the EVD.
Measured: 5 days
Secondary outcomes (8)
Diagnostic evaluation
Pupillometer ability to detect an EDV occlusion test failure will be studied. The area under the ROC curve (AUCROC) will be determined. We define, a priori, that the detection performance will be, respectively, honorable, good or excellent if the AUCROC is higher than 0.70, 0.80 and 0.90.
Measured: 5 days
Pupillometry and EVD occlusion test
Constriction velocity will be compared between two groups of patients (constituted a posteriori): success and failure of the occlusion test.
Measured: 5 days
Dilatation velocity
Dilation velocity will be compared between two groups of patients (constituted a posteriori): success and failure of the occlusion test.
Measured: 5 days
Maximum constriction velocity
Maximum constriction velocity will be compared between two groups of patients (constituted a posteriori): success and failure of the occlusion test.
Measured: 5 days
Latency of contraction
Latency of contraction will be compared between two groups of patients (constituted a posteriori): success and failure of the occlusion test.
Measured: 5 days
Pupil size variation
Pupil size variation will be compared between two groups of patients (constituted a posteriori): success and failure of the occlusion test.
Measured: 5 days
Pupillometry and clinical scores
The association between pupillometry parameters and clinical scores (Glasgow Coma Scale, FOUR score, RASS and CAM-ICU) will be studied
Measured: 5 days
The association between pupillometry parameters and ventricular volume will be studied.
A relationship between, measurements of ventricular volumes (via brain imaging examinations performed regardless of this study) and pupillometry parameters will be sought
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start31 May 2022 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HydrocephalusStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jérôme DAUVERGNE, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05386303
- Sponsor's protocol ID
- RC21_0078
- Acronym
- HYDRO-NiP
- Status last verified
- May 2021
- First submitted
- 19 May 2021
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Pupillometry During External Ventricular Drain Weaning - An Observational Study
- ClinicalTrials.gov ID
- NCT05386303
- Acronym / sponsor ID
- HYDRO-NiP / RC21_0078
- Conditions
- Hydrocephalus, Critical Care
- Keywords
- Pupillometry, External ventricular drain, Weaning, Brain injury, Pupillary reactivity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 31 May 2022 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 23 May 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.
The aim of this study is to assess the diagnostic ability of quantitative pupillometry for the early detection of hydrocephalus during the weaning process of the external ventricular drain.
Detailed description
Acute hydrocephalus is an emergency often requiring the insertion of an external ventricular drain (EVD). In the aftermath, the patient is transferred to an intensive care unit (ICU) for close monitoring. Ensuring optimal cerebral perfusion through efficient drainage of cerebrospinal fluid while minimizing drainage duration are the objectives of care.
Assessing pupillary light reflex is a key test for the detection of neurological deterioration. For long, this assessment has been grossly performed via a qualitative approach (present/absence of pupillary light reflex). For a more precise assessment, quantitative pupillometry has been proposed. Pupil size and constriction speed in response to a standard light are recorded by an automatic portable and user-friendly device. This device is increasingly used in the ICU, mostly for prognostication after acute brain injury. We hypothesized that quantitative pupillometry parameters may vary when hydrocephalus occurs.
The aim of this study is to assess whether quantitative pupillometry parameters vary when hydrocephalus occurs. The investigators focused on the early detection of hydrocephalus during the EVD weaning process.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult ICU patients with an EVD included at the beginning of the weaning process
Key inclusion criteria (4 listed)
- Patient older than 18 years old
- Admitted to the ICU
- With an external ventricular drain
- Consenting to participate (or consent from his/her next of kin, if unable to consent).
Key exclusion criteria (5 listed)
- Patient with pre-existing bilateral pupillary pathology
- Pregnant or breast-feeding patient
- Moribund patient or patient with decision of withholding or withdrawing life-sustaining treatment
- Patient with no health insurance
- Patient under guardianship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
NPi (Neurological Pupil index) and EVD (external ventricular drain)occlusion test
Time frame: 5 days
NPi will be compared between two groups of patients (constituted a posteriori): success and failure of the EVD occlusion test. Independently of this study, the EDV occlusion test starts as soon as prescribed by the physician as a prerequisite before its withdrawal. Failing an occlusion test is defined by the need for reopening the EVD.
8 secondary outcomes
Diagnostic evaluation
Time frame: 5 days
Pupillometry and EVD occlusion test
Time frame: 5 days
Dilatation velocity
Time frame: 5 days
Maximum constriction velocity
Time frame: 5 days
Latency of contraction
Time frame: 5 days
Pupil size variation
Time frame: 5 days
Pupillometry and clinical scores
Time frame: 5 days
The association between pupillometry parameters and ventricular volume will be studied.
Time frame: 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- Individual participant dataSharing planned: Undecided
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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.
Jérôme DAUVERGNE principal investigator
Nantes University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hydrocephalus and Critical Care, run by Nantes University Hospital at 2 sites 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jérôme DAUVERGNE, IDE (33 (0) 2.40.16.52.89, jerome.dauvergne@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NPi (Neurological Pupil index) and EVD (external ventricular drain)occlusion test (time frame: 5 days). 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 23 May 2022.