Inter-Device Reliability of the NPi-300 Pupillometer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-25

Study Completion Date

2022-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to explore the inter-device reliability between the NPi-200 and NPi-300.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Establishing Normative Data for Pupillometer Assessments in Neuro-Intensive Care

NCT02804438

Critical Illness Neuropathy

RECRUITING

Outcome pRognostication of Acute Brain Injury With the NeuroloGical Pupil indEx

NCT04490005

Acute Brain Injury Pupillary Reflex Impaired

COMPLETED

Interrater Reliability of Subjective Pupillary Assessments

NCT02296606

Interrater Reliability Among Pupillary Assessments

COMPLETED

The Neurological Pupil Index (NPi) on Intensive Care Unit (ICU) Trial

NCT01920347

Hypoxic Encephalopathy

COMPLETED

A Pilot Study for Pupillary Assessment to Predict CAR-T Related Neurotoxicity

NCT06144151

Neurotoxicity

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Critical Illness Neuropathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients

Patients with risk of cerebral edema.

NPi-200 and NPi-300 pupillometers

Intervention Type DEVICE

Device which measures PLR.

Healthy Control

Staff/Faculty who interact with patients at the enrolling site.

NPi-200 and NPi-300 pupillometers

Intervention Type DEVICE

Device which measures PLR.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

NPi-200 and NPi-300 pupillometers

Device which measures PLR.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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