Comparison of Tissue Oxygenation Measurement Using Multimodal Devices

NCT05784103 | Completed Results FDA Device

• 1 other identifier: 13895
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Oxygen Saturation

Keywords

SFDI, oxygenation, healthy volunteers

Outcome Measures

Primary Outcomes (3)

• Device-wise Comparison of Tissue Oxygenation Measurement

  4 devices used to measures the tissue oxygen saturation on healthy human volunteers

  Visit 1, up to 2 hours in duration

• Male vs Female Comparison of Tissue Oxygenation Measurement

  Goal is to see if there is a variation in the gender biased. The criteria for the male vs female comparison were considered to find better or worse outcomes.

  1 visit, 2hrs

• Skin Type Based Comparison of Tissue Oxygenation

  Fitzpatrick chart-based skin categorization of the skin type. The criteria for the Fitzpatrick Skin Type grades IV, II \& III were matched with Fitzpatric table and grades were considered to find better or worse outcomes. Please Note: The skin type analysis was performed irrespective to the devices. Only skin types were considered. So, there is no need of adding arms/groups other than the (1) Skin type IV and (2) the skin type II\& III.

  1 visit, 2hrs duration

Study Arms (1)

Multi-Modal Measurement of Oxygen Saturation

OTHER

During a single study visit, participants will have oxygen saturation measured with a number of oximetry devices including Spatial Frequency Domain Imaging (SFDI), Transcutaneous oxygen monitoring (TCOM), an Apple Watch Oxygen Sensor, and a Pulse Oximeter. Each device will be used to measure oxygen saturation of the thumb and index fingers at rest, during occlusion of blood flow to the arm (using an inflated blood pressure cuff applied to the arm), and during the hyperemic post-occlusion period. Completion of all planned interventions may take up to 2 hours on the study visit day.

Device: Clarifi Modulum; Device: Perimed PeriFlux 5000; Device: Apple Watch Oxygen Sensor; Device: Innovo iP 900AP

Interventions

Clarifi Modulum DEVICE

During consenting period, the Modulim equipment will be calibrated and setup ready for scanning. Subject's volar aspect of the thumb along with the palm surface will be ready to target the optical camera head. Actual scanning takes less than 60 seconds. The images will be processed offline. During processing 3-5 different regions of interest will be taken to measure the oxygen parameters such as tissue oxygen saturation, oxy-hemoglobin, deoxy-hemoglobin, superficial hemoglobin, and sub-surface hemoglobin.

Also known as: Spatial Frequency Domain Imaging (SFDI)

Multi-Modal Measurement of Oxygen Saturation

Perimed PeriFlux 5000 DEVICE

Transcutaneous oxygen monitoring (TCOM or TcpO2) is a noninvasive, clinically-approved method to obtain skin oxygen levels. The method is quantitative, and measures oxygen delivery to the skin from underlying tissue. Before positioning the electrode, an adhesive fixation ring will be placed on the dry skin on the volar aspect of the thumb and an electrolyte as a contact liquid will be filled half and the probe is aligned into it by rotating clock-wise to fasten it. Recording will be started and waited for the oxygen level to stabilize and a fixed value will be recorded. The probe will be heated to about 45oC. Although this device has other options, only the measurement of O2 will be performed using this device.

Also known as: Transcutaneous oxygen monitoring (TCOM)

Multi-Modal Measurement of Oxygen Saturation

Apple Watch Oxygen Sensor DEVICE

The apple watch is equipped with green, red, and infrared LEDs that shine light onto the blood vessels in the wrist, with photodiodes measuring the amount of light reflected back. Apple's algorithms use this information to calculate the color of the blood, which is an indication of how much oxygen is in the blood. Bright red blood is well oxygenated, while darker blood has less oxygen. This can measure blood oxygen levels between 70 and 100 percent. Most healthy people have blood oxygen levels that range from 95 to 100 percent. The apple watch sensor will be positioned on the user's preferred wrist.

Multi-Modal Measurement of Oxygen Saturation

Innovo iP 900AP DEVICE

The pulse oximeter enables transcutaneous monitoring of the oxygen saturation of hemoglobin in arterial blood. In this study, volar aspect of thumb and index finder of the subject will be used to measure blood oxygen saturation.

Also known as: Pulse Oximeter

Multi-Modal Measurement of Oxygen Saturation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients or limited health conditions
• Smoking tobacco product
• Prisoners
• Cannot consent for themselves

Sponsors & Collaborators

• Indiana University: lead

Study Sites (2)

Indiana University, School of Medicine

Indianapolis, Indiana, 15219/46202, United States

Location

Surya C. Gnyawali, University of Pittsburgh, UPMC

Pittsburgh, Pennsylvania, 15227, United States

Location

Related Publications (2)

• Jones MD, Taylor JL, Barry BK. Occlusion of blood flow attenuates exercise-induced hypoalgesia in the occluded limb of healthy adults. J Appl Physiol (1985). 2017 May 1;122(5):1284-1291. doi: 10.1152/japplphysiol.01004.2016. Epub 2017 Feb 9.

  PMID: 28183823 RESULT

• El Masry M, Li R, Balasubramani GK, Roy S, Sen CK, Gnyawali SC. Comparative assessment of healthy tissue oxygenation using near-infrared imaging, transcutaneous oxygen measurement, and plethysmography. Sci Rep. 2025 Aug 19;15(1):30424. doi: 10.1038/s41598-025-15767-2.

  PMID: 40830190 DERIVED

Limitations and Caveats

The study includes a small cohort of 20 volunteers. Aim was to include dark skin volunteers but that was not successful.

Results Point of Contact

• Title: Dr. Surya Gnyawali, PhD
• Organization: University of Pittsburgh

scg92@pitt.edu

6143712027

Study Officials

• Surya C. Gnyawali, PhD

  University of Pittsburgh and Indiana University, School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Professor

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: March 24, 2023
• Study Start: March 9, 2022
• Primary Completion: July 7, 2022
• Study Completion: July 7, 2022
• Last Updated: November 29, 2023
• Results First Posted: November 24, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)