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

Not Applicable

Withdrawn

• Conditions: Brain Injuries
• Interventions: Device: Licox® Brain Tissue Oxygen Monitoring System; Device: Near-infrared spectroscopy (NIRS)

• Registration Number: NCT04247321
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-28
• Study First Submitted QC: 2020-01-28
• Study First Posted: 2020-01-30
• Status Verified: 2021-09
• Study Start: 2021-09-01
• Last Update Submitted: 2021-09-28
• Last Update Posted: 2021-10-05
• Primary Completion: 2023-06-01
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Subjects with acute brain injury	Licox® Brain Tissue Oxygen Monitoring System	Subjects requiring placement of a Licox Brain Tissue Oxygen device for their clinical care will also have Near-infrared spectroscopy (NIRS) monitoring system placed
Subjects with acute brain injury	Near-infrared spectroscopy (NIRS)	Subjects requiring placement of a Licox Brain Tissue Oxygen device for their clinical care will also have Near-infrared spectroscopy (NIRS) monitoring system placed

Primary Outcome Measures

Name	Time	Method
Correlation between changes in Licox and NIRS oxygenation measurements	3 to 5 days of the monitoring duration	Licox measures oxygenation in terms of partial pressure (PtO2) and NIRS measures it in terms of saturation (rSO2). The changes in PtO2 versus the changes in rSO2 will be compared for equivalence.

Secondary Outcome Measures

Name	Time	Method
Correlation between changes in pressure reactivity index and Licox versus NIRS	3 to 5 days of the monitoring duration	The pressure reactivity index (PRx) is derived using ICM+ software; the PRx is a correlation coefficient ranging from -1 to +1; PRx \> 0 indicates poor autoregulation. We will investigate if PRx correlates with changes in rSO2 as measured by NIRS (if changes in autoregulation correspond with changes in oxygenation).

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States