Unresolved instrumentation problems following clinical trials using near infrared spectroscopy

Area of Science:

• Biomedical Engineering
• Clinical Instrumentation

Background:

• Near infrared spectroscopy (NIRS) is utilized in clinical settings.
• Seven years of NIRS clinical trials revealed persistent engineering issues.

Purpose of the Study:

• To summarize existing studies on NIRS engineering problems.
• To present new data highlighting the need for NIRS technological improvements.
• To inform instrument designers about critical areas for enhancement.

Main Methods:

• Review of previously published studies on NIRS.
• Presentation of new data from clinical trials.
• Analysis of engineering challenges including fiber optic failure, electromagnetic interference, and software algorithms.

Main Results:

• Identified recurring engineering problems in NIRS instruments.
• Observed negative impacts on clinical practice, including data rejection and resource diversion.
• Highlighted specific issues: fiber optic failure, electromagnetic interference, chromophore algorithms, and computational software.

Conclusions:

• Significant improvements in NIRS technology are necessary.
• Enhanced NIRS instruments are vital for reliable clinical data acquisition.
• Addressing engineering flaws will enable better definition of clinical management protocols.