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N/A N=20 Other

Comparison of Tissue Oxygenation Measurement Using Multimodal Devices

Oxygen Saturation

Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcome: Primary: Device-wise Comparison of Tissue Oxygenation Measurement — 62.7; 91.2; 97.58; 97.95 percentage of oxygen

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Clarifi Modulum (Device); Perimed PeriFlux 5000 (Device); Apple Watch Oxygen Sensor (Device); Innovo iP 900AP (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Indiana University
Primary completion
Jul 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Device-wise Comparison of Tissue Oxygenation Measurement
62.7; 91.2; 97.58; 97.95; 44.8; 67.95
PRIMARY
Male vs Female Comparison of Tissue Oxygenation Measurement
61.40; 94.15; 97.43; 97.87; 65.48; 85.61
PRIMARY
Skin Type Based Comparison of Tissue Oxygenation
21.62; 24.64

Summary

Pulse oximeters are common medical devices used to measure blood oxygen saturation (SpO2). These devices are either stand-alone or integrated into physiologic monitoring systems, using 2 wavelengths of light to determine SpO2. With recent advances in technology, Spatial Frequency Domain Imaging (SFDI) uses a range of light wavelengths from red to near-infrared (NIR), and smartphones such as Apple Watch, and transcutaneous oximetry TCOM now have pulse oximetry capabilities. Since it is possible that most patients could utilize this technology, we sought to assess the accuracy, reliability, and usability of these oximeters and compare outcomes. In this study, a cohort of 20 healthy volunteers above the age of 18 including males and females of different skin colors will be assessed at the same site and data will be compared. We aim to provide a set of data that will support the clinical and scientific community and identify more than one reliable skin oxygen measurement modality.

Eligibility Criteria

Inclusion Criteria

  • Healthy volunteers
  • Able to understand and complete the Informed Consent
  • Both males and females
  • Age between 18-65 years
  • All ethnic backgrounds

Exclusion Criteria

  • Patients or limited health conditions
  • Smoking tobacco product
  • Prisoners
  • Cannot consent for themselves
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05784103). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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