Trial Outcomes & Findings for Comparison of Tissue Oxygenation Measurement Using Multimodal Devices (NCT NCT05784103)

NCT ID: NCT05784103

Last Updated: 2023-11-29

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

Visit 1, up to 2 hours in duration

Results posted on

2023-11-29

Participant Flow

Participant milestones

Participant milestones
Measure	Multi-modal Measurement of Tissue Oxygenation SFDI: StO2= tissue oxygen saturation HbO2=oxy hemoglobin HbR= deoxyhemoglobin HbT1= superficial perfusion hemoglobin HbT2= deep perfusion hemoglobin TCOM=trans-cutaneous oxygen measurement SFDI=spatial frequency domain imaging
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Tissue Oxygenation Measurement Using Multimodal Devices

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Multi-Modal Measurement of Tissue Oxygenation on Healthy Volunteers n=20 Participants In a single study visit, oxygen saturation was measured on participants with SFDI, TCOM, Apple Watch Oxygen Sensor, and a Pulse Oximeter. The thumb and index fingers are at rest, during the occlusion, and during the hyperemic post-occlusion period. Completion of all planned interventions may take up to 2 hours on the study visit day. Modulum: Equipment will be calibrated and set up ready for scanning. volar aspect of the thumb surface imaged. parameters: tissue oxygen saturation, oxy-hemoglobin, deoxy-hemoglobin, superficial hemoglobin, and sub-surface hemoglobin. PeriFlux 5000: tcpO2 is a noninvasive, clinically-approved method to obtain skin oxygen levels. The probe is placed on dry skin on the volar aspect of the thumb. A recording will be started and waited for the oxygen level to stabilize and a fixed value will be recorded. Apple Watch Oxygen Sensor: The Apple watch wrist's Bright red blood is well-oxygenated, while darker blood has less oxygen. Can measure blood oxygen levels between 70 and 100 percent. Healthy people have blood oxygen levels that range from 95 to 100 percent. Oximeter: The pulse oximeter enables monitoring of the oxyhemoglobin in arterial blood. volar aspect index finder of the subject was used to measure blood oxygen saturation.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	34.2 years STANDARD_DEVIATION 6.06 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	10 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Visit 1, up to 2 hours in duration

Population: The Apple watch and the Pulse Oximeters are the devices designed to measure blood oxygenation based on the blood pulses occurring in the blood vessels when there is actual flow. At the time of occlusion there is no blood vessels pulsating, so the data were measured zero.

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

Outcome measures

Outcome measures
Measure	SFDI n=20 Participants During a single study visit, participants will have oxygen saturation measured with Spatial Frequency Domain Imaging (SFDI). 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.	TCOM n=20 Participants During a single study visit, participants will have oxygen saturation measured with TCOM. measure oxygen partial pressure 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.	Apple Watch n=20 Participants During a single study visit, participants will have oxygen saturation measured with the Apple Watch application. measure oxygenation 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.	Pulse Oximeter n=20 Participants During a single study visit, participants will have oxygen saturation measured with Pulse Oximeter. measure oxygenation 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-wise Comparison of Tissue Oxygenation Measurement baseline	62.7 percentage of oxygen Standard Deviation 18.11	91.2 percentage of oxygen Standard Deviation 11.98	97.58 percentage of oxygen Standard Deviation 1.14	97.95 percentage of oxygen Standard Deviation 1.05
Device-wise Comparison of Tissue Oxygenation Measurement during occlusion	44.8 percentage of oxygen Standard Deviation 16.03	67.95 percentage of oxygen Standard Deviation 14.97	0 percentage of oxygen Standard Deviation 0	0 percentage of oxygen Standard Deviation 0
Device-wise Comparison of Tissue Oxygenation Measurement reactive hyperamia	71.1 percentage of oxygen Standard Deviation 17.41	87.21 percentage of oxygen Standard Deviation 9.09	97.88 percentage of oxygen Standard Deviation 1.16	99.24 percentage of oxygen Standard Deviation 1.09
Device-wise Comparison of Tissue Oxygenation Measurement Recovery	65.8 percentage of oxygen Standard Deviation 17.94	79.9 percentage of oxygen Standard Deviation 10.70	97.50 percentage of oxygen Standard Deviation 1.12	97.56 percentage of oxygen Standard Deviation 1.04

PRIMARY outcome

Timeframe: 1 visit, 2hrs

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.

Outcome measures

Outcome measures
Measure	SFDI n=20 Participants During a single study visit, participants will have oxygen saturation measured with Spatial Frequency Domain Imaging (SFDI). 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.	TCOM n=20 Participants During a single study visit, participants will have oxygen saturation measured with TCOM. measure oxygen partial pressure 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.	Apple Watch n=20 Participants During a single study visit, participants will have oxygen saturation measured with the Apple Watch application. measure oxygenation 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.	Pulse Oximeter n=20 Participants During a single study visit, participants will have oxygen saturation measured with Pulse Oximeter. measure oxygenation 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.
Male vs Female Comparison of Tissue Oxygenation Measurement Male	61.40 percentage of Oxygen Standard Deviation 21.75	94.15 percentage of Oxygen Standard Deviation 10.67	97.43 percentage of Oxygen Standard Deviation 1.00	97.87 percentage of Oxygen Standard Deviation 0.91
Male vs Female Comparison of Tissue Oxygenation Measurement Female	65.48 percentage of Oxygen Standard Deviation 6.48	85.61 percentage of Oxygen Standard Deviation 14.54	97.85 percentage of Oxygen Standard Deviation 0.96	98.09 percentage of Oxygen Standard Deviation 0.62

PRIMARY outcome

Timeframe: 1 visit, 2hrs duration

Population: Type II: Fitzpatrick grades were according to the following criteria:- Fair skin, blue eyes; burns easily, tans poorly. Type III: Fitzpatrick grades were according to the following criteria:- Darker white skin; tans after initial burn. Type IV: Fitzpatrick grades were according to the following criteria:- Light brown skin; burns minimally, tans easily. This was used to grade from the Fitzpatrick skin type scale questionnaire.

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.

Outcome measures

Outcome measures
Measure	SFDI n=7 Participants During a single study visit, participants will have oxygen saturation measured with Spatial Frequency Domain Imaging (SFDI). 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.	TCOM n=13 Participants During a single study visit, participants will have oxygen saturation measured with TCOM. measure oxygen partial pressure 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.	Apple Watch During a single study visit, participants will have oxygen saturation measured with the Apple Watch application. measure oxygenation 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.	Pulse Oximeter During a single study visit, participants will have oxygen saturation measured with Pulse Oximeter. measure oxygenation 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.
Skin Type Based Comparison of Tissue Oxygenation	21.62 percentage of oxygen Standard Deviation 3.09	24.64 percentage of oxygen Standard Deviation 2.66	—	—

Adverse Events

SFDI Measurement of Oxygen Saturation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PeriFlux 5000 for Transcutaneous Oxygen Partial Pressure

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Apple Watch Oxygen Sensor for Arterial Oxygenation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

A Pulse Oximeter for Arterial Oxygenation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Surya Gnyawali, PhD

University of Pittsburgh

Phone: 6143712027

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place