Transcutaneous Pulse Oximetry Brain Monitoring Study (US)

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

RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-27

Study Completion Date

2024-11-30

Brief Summary

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

This is a study of adult patients with a severe and sudden brain injury who have a drain placed in their brain to measure pressure. The purpose of the study is to monitor the pressure in the brain using a monitor placed on the forehead, and compare this to a drain placed in the brain.

Related Clinical Trials

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

The Use of Tissue Oxygen Monitoring in Critically Injured Patients

NCT00328341

Traumatic Brain Injury Hemorrhagic Shock Trauma

TERMINATED

Intensive Monitoring of Brain Injured Patients

NCT00163774

Traumatic Brain Injury

COMPLETED NA

Brain Oximeter Calibration and Validation Study

NCT05397704

Brain Injuries, Traumatic

COMPLETED NA

Invasive and Non-Invasive Assessment of Cerebral Oxygenation in Patients With Severe Traumatic Brain Injury (TBI)

NCT00703495

Brain Injuries

COMPLETED

Characterizing the cerebrovAscular Physiology of Optimal Mean Arterial Pressure Targeted Resuscitation

NCT03609333

Cardiac Arrest

COMPLETED NA

Detailed Description

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

The device is a non-invasive brain pulse oximeter. It uses red and near-infrared light and provides a signal which represents the change in blood volume associated with each heartbeat.

The brain signal allows a number of clinically important end-points to be determined, including brain blood flow, oxygen and pressure levels.

The T-Pot (US) Study will be undertaken in patients that require invasive brain monitoring.

The primary aim of the study is to assess the accuracy of the brain pulse oximeter compared with the traditional invasive intracranial pressure (ICP) monitoring.

Conditions

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

Acute Brain Injury

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

Single center prospective observational cohort study

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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

Enrolled patients

All enrolled patients will have brain pulse monitoring

Group Type OTHER

Brain Pulse Oximeter

Intervention Type DEVICE

Sensor is placed on the right and/or left forehead and maintained with an elasticized headband. The duration of monitoring will last for approximately 60 minutes per monitoring session to obtain sufficient data. Serial monitoring will occur on three consecutive days.

Interventions

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

Brain Pulse Oximeter

Sensor is placed on the right and/or left forehead and maintained with an elasticized headband. The duration of monitoring will last for approximately 60 minutes per monitoring session to obtain sufficient data. Serial monitoring will occur on three consecutive days.

Intervention Type DEVICE

Eligibility Criteria

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

Inclusion Criteria

* 1\. Adult brain-injured patients who have undergone external ventricular drain insertion for cerebrospinal fluid drainage and invasive intracranial pressure monitoring as part of standard medical care
* 2\. Adult brain-injured patients who have undergone external ventricular drain insertion for cerebrospinal fluid drainage and invasive intracranial pressure monitoring that have concomitant continuous electroencephalography (EEG) monitoring as part of standard medical care

Exclusion Criteria

* 1\. Inability to obtain the brain pulse oximeter signal from at least one brain hemisphere due to interface issue such as severe agitation, head dressing, severe skin or bone trauma, or skull removal preventing brain pulse detection for the initial monitoring session.

a. Note: If unable to obtain brain pulse oximeter signal for subsequent monitoring sessions, the only the recordings that were obtained will be used for analysis
* 2\. Hemodynamically unstable patients (defined as increasing vasopressors requirements)
* 3\. Patients with unstable mechanical ventilation support defined as increasing fractional inspired oxygen (FiO2) requirements

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No