Comparison of Tissue Oxygenation Measurement Using Multimodal Devices

Oxygen Saturation Clinical Trial

Official title:

Measurement of Oxygen Saturation in Healthy Human Volunteers Before, During, and After Hyperemic Events Using Multi-Modal Techniques: Spatial Frequency Domain Imaging, Transcutaneous Oxygen Measurement, Pulse Oximeter, and Apple Watch

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05784103
• Other study ID #: 13895
• Status: Completed
• Phase: N/A
• Start date: March 9, 2022
• Est. completion date: July 7, 2022

Study information

• Verified date: November 2023
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The subjects will go through a questionnaire session about their medical history by a designated study team member. The questionnaire data will be placed in RedCap using a subject ID that cannot be linked back to the subject. Then the subject will consent and be enrolled. Then the non-invasive data-collecting procedure will start on the following equipment.

Spatial Frequency Domain Imaging (SFDI): During the consenting period, the Modulim equipment will be calibrated and set up ready for scanning. The 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 (ROI) will be taken to measure the oxygen parameters such as tissue oxygen saturation (StO2), oxy-hemoglobin (HbO2), deoxy-hemoglobin (HbR), superficial hemoglobin (HbT1, sub-surface hemoglobin (HbT2). The model used is a Clarifi Modulim Transcutaneous oxygen monitoring (TCOM): 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 in half and the probe is aligned into it by rotating clockwise to fasten it. The recording will be started and waited for the oxygen level to stabilize and a fixed value will be recorded. The model used is a Perimed PeriFlux 5000. The probe will be heated to about 45 degrees C. Although this device has other options, only the measurement of O2 will be performed using this device.

Apple Watch Oxygen Sensor: Smartwatch blood oxygen sensors also measure blood oxygen levels in the tissue. Apple Watch Series 6 introduced this new feature for monitoring blood oxygen levels using light-emitting diodes (LEDs) at the back of apple watches. A low blood oxygen level can be indicative of a serious health issue that needs immediate attention. 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.

Pulse Oximeter for Oxygen Monitoring: The pulse oximeter enables transcutaneous monitoring of the oxygen saturation of hemoglobin in arterial blood (StO2). Pulse oximetry is so widely prevalent in medical care that it is often regarded as a fifth vital sign[3]. It is important to understand how the technology functions as well as its limitations. To recognize the settings in which pulse oximeter readings of oxygen saturation (SpO2), an understanding of two basic principles of pulse oximetry is required: (i) how oxyhemoglobin (HbO2) is distinguished from deoxyhemoglobin (HbR) and (ii) how the SpO2 is calculated only from the arterial compartment of blood. Pulse oximetry is based on the principle that HbO2 and HbR differentially absorb red and near-infrared (IR) light. It is fortuitous that HbO2 and HbR have significant differences in absorption at red and near-IR light because these two wavelengths penetrate tissues well whereas blue, green, yellow, and far-IR light are significantly absorbed by non-vascular tissues and water [3]. HbO2 absorbs greater amounts of IR light and lower amounts of red light than does HbR; this is consistent with experience - well-oxygenated blood with its higher concentrations of HbO2 appears bright red to the eye because it scatters more red light than does HbR. On the other hand, HHR absorbs more red light and appears less red. Exploiting this difference in light absorption properties between HbO2 and HbR, pulse oximeters emit two wavelengths of light, red at 660 nm and near-IR at 940 nm from a pair of small light-emitting diodes located in one arm of the finger probe. The light that is transmitted through the finger is then detected by a photodiode on the opposite arm of the probe. In this study, the volar aspect of the thumb and index finger of the subject will be used to measure SpO2.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 7, 2022
• Est. primary completion date: July 7, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Oxygen Saturation

Intervention

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

Locations

Country	Name	City	State
United States	Indiana University, School of Medicine	Indianapolis	Indiana
United States	Surya C. Gnyawali, University of Pittsburgh, UPMC	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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