Transcutaneous pulse oximetry brain monitoring study

Not Applicable

• Conditions: Patients with a brain injury requiring invasive brain oxygen; Injury, Occupational Diseases, Poisoning

• Registration Number: ISRCTN28562529
• Lead Sponsor: Cyban Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-05-09
• Last Update Posted: 20 June 2023
• Study Completion: 2024-08-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Patients with invasive brain oxygen monitoring as part of their routine care

Exclusion Criteria

1. Brain pulse oximeter signal cannot be obtained from at least one brain hemisphere due to an interference issue such as head dressing, severe skin or bone trauma or skull removal preventing brain pulse detection
2. Invasive PbtO2 monitor output believed to be inaccurate by ICU clinicians due to technical limitations with the device

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Brain oxygen levels measured using both the brain pulse oximeter and conventional skin pulse oximeter during the study

Secondary Outcome Measures

Name	Time	Method
Brain oxygen levels where PbtO2 < 20 mmHg or < 15 mmHg measured using both the brain pulse oximeter and conventional skin pulse oximeter to assess the accuracy to detect an episode during the study