N/A
N=20
Comparison of Tissue Oxygenation Measurement Using Multimodal Devices
Oxygen Saturation
Bottom Line
View on ClinicalTrials.gov: NCT05784103 ↗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
| Outcome | Result | p-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
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.