Transcutaneous Pulse Oximetry Brain Monitoring Study (US)

Launched by CYBAN PTY LTD · Feb 18, 2024

Keywords

ClinConnect Summary

The Transcutaneous Pulse Oximetry Brain Monitoring Study is looking at a new way to monitor brain pressure in adults who have experienced a severe brain injury and have a device called an external ventricular drain (EVD) placed in their brain. This device is typically used to help drain excess fluid and monitor pressure inside the skull. In this study, researchers want to see if a monitor placed on the forehead can provide accurate information about brain pressure, comparing it to the readings from the EVD. This study is currently recruiting participants aged 18 and older who have undergone this procedure as part of their care.

To be eligible for the study, participants must have had an EVD inserted to help manage their brain injury and may also be monitored with continuous EEG (a test that measures brain activity). However, individuals who are too unstable or cannot get a reliable reading from the forehead monitor due to other conditions may not be able to participate. Those who join the study will help researchers learn more about this new monitoring method, which could potentially improve care for patients with acute brain injuries in the future.

Gender

ALL

Eligibility criteria

• 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