Critical IllnessTRIPLENCT04993833
Inter-Device Reliability of the NPi-300 Pupillometer
An observational study of Critical Illness and Neuropathy, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to explore the inter-device reliability between the NPi-200 and NPi-300. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Critical Illness, Neuropathy
- What is being tested?
- NPi-200 and NPi-300 pupillometers
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2021to 31 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patient Cohort: Patients admitted with a neurological or neurosurgical diagnosis that place them at risk for cerebral edema. Healthy Cohort: Faculty/Staff who interact with patients at the enrolling site
Who may be able to join
- Subjects will be included if they are adults (>18 years of age) and have a neurological or neurosurgical diagnosis that place them at risk for cerebral edema. Subjects also have to be admitted to the enrolling site. Persons consenting for the study (whether patient or LAR) will need to be able to consent for the study in English.
- Staff in the enrolling site
Who cannot join
- Patients that will be excluded from the study are those that are prisoners, under 18 years of age, or pregnant women.
- None
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to explore the inter-device reliability between the NPi-200 and NPi-300.
Read the detailed description
Paired assessments will be made on patients who are consented; and on healthy controls who have verbally assented to participate. We plan to enroll 20 patients and 50 healthy controls. Assessments will be made at the convenience of the patient and healthy controls. Each assessment will include bilateral PLR reading within a 5 minute interval. The first assessment will be completed with the NPi-200 and the second assessment will use the NPi-300. The data will be entered into a CRF.
If there is a significant difference between readings from the NPi-200 and the NPi-300, we will repeat the bilateral assessment in the following hour and the regularly scheduled time.
- Conditions
- Critical Illness, Neuropathy
- Being tested
- NPi-200 and NPi-300 pupillometers
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NPi-200 and NPi-300 pupillometersDevice
Device which measures PLR.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients with risk of cerebral edema. Receives: Device: NPi-200 and NPi-300 pupillometers | |
| Healthy Control | Staff/Faculty who interact with patients at the enrolling site. Receives: Device: NPi-200 and NPi-300 pupillometers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pupil's reaction to light as measured by Neurological Pupil Index (NPI)
Pupil's reaction to light as measured by Neurological Pupil Index (NPI) algorithm using pupillometer device that grades the pupil's reaction to light on a scale between 0 and 5. The Inter-device reliability is assessed using Cohen's Kappa method: values ≤ 0 as indicating no agreement.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start25 Aug 2021
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- NeurOptics Inc
- Responsible party
- Principal investigator, DaiWai Olson, University of Texas Southwestern Medical Center
- Investigators
- DaiWai M Olson, PhD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04993833
- Sponsor's protocol ID
- STU-2021-0693
- Acronym
- TRIPLE
- Status last verified
- Sep 2022
- First submitted
- 13 Jul 2021
- Last updated
- 30 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inter-Device Reliability of the NPi-300 Pupillometer
- ClinicalTrials.gov ID
- NCT04993833
- Acronym / sponsor ID
- TRIPLE / STU-2021-0693
- Conditions
- Critical Illness, Neuropathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- NeurOptics Inc
- Study start
- 25 Aug 2021 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 6 Aug 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.
The purpose of this study is to explore the inter-device reliability between the NPi-200 and NPi-300.
Detailed description
Paired assessments will be made on patients who are consented; and on healthy controls who have verbally assented to participate. We plan to enroll 20 patients and 50 healthy controls. Assessments will be made at the convenience of the patient and healthy controls. Each assessment will include bilateral PLR reading within a 5 minute interval. The first assessment will be completed with the NPi-200 and the second assessment will use the NPi-300. The data will be entered into a CRF.
If there is a significant difference between readings from the NPi-200 and the NPi-300, we will repeat the bilateral assessment in the following hour and the regularly scheduled time.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Device: NPi-200 and NPi-300 pupillometersPatients with risk of cerebral edema. |
| Healthy Control | – | Device: NPi-200 and NPi-300 pupillometersStaff/Faculty who interact with patients at the enrolling site. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patient Cohort: Patients admitted with a neurological or neurosurgical diagnosis that place them at risk for cerebral edema. Healthy Cohort: Faculty/Staff who interact with patients at the enrolling site
Key inclusion criteria (2 listed)
- Subjects will be included if they are adults (>18 years of age) and have a neurological or neurosurgical diagnosis that place them at risk for cerebral edema. Subjects also have to be admitted to the enrolling site. Persons consenting for the study (whether patient or LAR) will need to be able to consent for the study in English.
- Staff in the enrolling site
Key exclusion criteria (2 listed)
- Patients that will be excluded from the study are those that are prisoners, under 18 years of age, or pregnant women.
- None
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 |
|---|---|---|
| NPi-200 and NPi-300 pupillometersDevice which measures PLR. | Device | Healthy Control, Patients |
Primary outcome
Pupil's reaction to light as measured by Neurological Pupil Index (NPI)
Time frame: 1 year
Pupil's reaction to light as measured by Neurological Pupil Index (NPI) algorithm using pupillometer device that grades the pupil's reaction to light on a scale between 0 and 5. The Inter-device reliability is assessed using Cohen's Kappa method: values ≤ 0 as indicating no agreement.
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 30 Sep 2022.
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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.
DaiWai M Olson, PhD principal investigator
University of Texas Southwestern Medical Center
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 Critical Illness and Neuropathy, run by University of Texas Southwestern Medical Center at 1 site in United States.
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 30 Sep 2022. 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 States. 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?
Pupil's reaction to light as measured by Neurological Pupil Index (NPI) (time frame: 1 year). 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 30 Sep 2022.