NCT06267131

Transcutaneous Pulse Oximetry Brain Monitoring Study (US)

Transcutaneous Pulse Oximetry Brain Monitoring Study (US): T-POT Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Cyban Pty Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

• Acute Brain Injury

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2023-10-27
• Primary completion: 2024-11-01
• Completion: 2024-11-01
• First posted: 2024-02-20
• Last updated: 2024-02-20

Locations

1 site across 1 country: United States