Non-invasive Near-infrared Spectroscopy (NIRS) Versus Invasive Licox Intracranial Pressure

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2023-06-01

Brief Summary

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

Researchers are trying to assess how accurately and safely NIRS non-invasive monitoring can detect changes in intracranial pressure to determine if this noninvasive device can be used instead of invasive monitoring with Licox in the future.

Related Clinical Trials

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

Correlating Brain Tissue Oxygen and Regional Cerebral Oximetry

NCT03128957

Stroke

COMPLETED NA

Correlation Between Noninvasive Blood Vessel Functionality Parameters and Cerebral Hemodynamics in Neurocritical Care Patients

NCT06511804

Brain Injuries Intracranial Pressure Increase Monitoring

RECRUITING

Validation of Next Generation Cerebral and Tissue Oximeter

NCT03128372

Oxygen Deficiency

COMPLETED NA

Development of an Algorithm for Prediction of Onset of Hemodynamic Instability in Humans

NCT00581204

Hemorrhagic Shock

COMPLETED

Near Infrared Spectroscopy and Transcutaneous Oxygen Pressure in Critical Limb Ischemia Before and After Treatment

NCT01459341

Peripheral Vascular Disease Critical Limb Ischemia

COMPLETED

Detailed Description

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

Conditions

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

Brain Injuries

Study Design

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

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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

Subjects with acute brain injury

Subjects requiring placement of a Licox Brain Tissue Oxygen device for their clinical care will also have Near-infrared spectroscopy (NIRS) monitoring system placed

Group Type EXPERIMENTAL

Licox® Brain Tissue Oxygen Monitoring System

Intervention Type DEVICE

Invasive brain tissue oxygenation monitoring

Near-infrared spectroscopy (NIRS)

Intervention Type DEVICE

Non-invasive approach to monitoring brain tissue oxygenation which uses two wavelengths of near infrared light and takes measurements of the ratio of oxyhemoglobin to total hemoglobin

Interventions

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

Licox® Brain Tissue Oxygen Monitoring System

Invasive brain tissue oxygenation monitoring

Intervention Type DEVICE

Near-infrared spectroscopy (NIRS)

Non-invasive approach to monitoring brain tissue oxygenation which uses two wavelengths of near infrared light and takes measurements of the ratio of oxyhemoglobin to total hemoglobin

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 with acute brain injury who are age ≥ 18
* Glasgow coma scale score (GCS) ≤ 8
* Neuroimaging concerning for ICP crises, or have active ICP treatment
* Have Licox Brain Tissue Oxygen monitor placed as standard of care treatment

Exclusion:

* CNS infection
* Bleeding diathesis or thrombocytopenia \< 50,000 platelets
* Subjects with subdural hematomas who have had surgical decompression and bone flap removal

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No