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RDS MultiSense® SpO2 Calibration

Primary Purpose

Hypoxia

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Pulse Oximeter, Respiratory Rate, Heart Rate

About this trial

This is an interventional other trial for Hypoxia focused on measuring Hypoxia, Pulse Oximetry, SpO2, Remote monitoring, Connected device, Real-time monitoring

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Subject must have the ability to understand and provide written informed consent
Subject is 18 to 50 years of age
Subject must be willing and able to comply with study procedures and duration
Subject is a non-smoker or who has not smoked within 2 days prior to the study.
Male or female of any race
Subject demographics include a range of skin pigmentations, including at least 3 darkly pigmented subjects or 15% of the subject pool, whichever is larger.

Exclusion Criteria:

Subject is considered as being morbidly obese (defined as BMI >39.5)
Compromised circulation, injury, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor sites, tattoo in the optical path which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow subjects to participate if the condition is noted and would not affect the particular sites utilized.)
Females who are pregnant, who are trying to get pregnant, (confirmed by positive urine pregnancy test unless the subject is known to be not of child-bearing potential)
Subjects who have smoked in the last 2 days with COHb levels >3% as assessed with a Masimo Radical 7 (Rainbow)
Subjects with known respiratory conditions (self-reported)
Subjects with known heart or cardiovascular conditions (self-reported, except for blood pressure and ECG review) or with an implantable active medical device such as pacemaker or automatic defibrillator
Self-reported health conditions as identified in the Health Assessment Form (self-reported)
Subjects with severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors (self-reported)
Unwillingness or inability to remove colored nail polish from test digits.
Unwillingness to have chest or other test site shaved
Other known health condition, should be considered upon disclosure in health assessment form

Sites / Locations

Clinimark LLC

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Controled Hypoxia - Healthy volunteer

Arm Description

Male and female subjects, ranging in pigmentation from light to dark

Outcomes

Primary Outcome Measures

Determination of the quality of measurements of arterial blood saturation (SpO2) provided by the MultiSense® system in comparison to measurements made with a reference Pulse Oximetry System, in terms of accuracy.

Accuracy is defined as an average measurement variation less than 3.5% of the mean value to the reference standard. Reference Pulse Oximetry Systems, previously compared to Reference CO-Oximetry will be used as the basis for comparison. The study population will include 15 to 50 subjects. The data for analysis will be equally distributed across the range of 70-100%. All data will be used for the analysis unless identified as unstable by the control oximeter. Data that is found to be unstable will be removed prior to the comparative analysis.

Secondary Outcome Measures

Full Information

NCT ID

NCT05466942

First Posted

July 8, 2022

Last Updated

March 28, 2023

Sponsor

Rhythm Diagnostic Systems

Collaborators

Clinimark, LLC

1. Study Identification

Unique Protocol Identification Number

NCT05466942

Brief Title

RDS MultiSense® SpO2 Calibration

Official Title

RDS MultiSense® SpO2 Calibration

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

March 15, 2022 (Actual)

Primary Completion Date

March 17, 2022 (Actual)

Study Completion Date

April 17, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rhythm Diagnostic Systems

Collaborators

Clinimark, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

Data will be collected with the MultiSense® pulse oximetry system during non-motion conditions over the range of 70-100%. A Clinimark reference system, previously correlated to arterial blood CO-Oximetry will be the basis for comparison. A minimum of fifteen (15) up to fifty (50) healthy adult subjects, ranging in pigmentation from light to dark, with at least six (6) subjects with dark pigmentation (Fitzpatrick 5-6), will be enrolled in the study to meet the study design requirements defined by ISO 80601-2-61 and by the FDA's Guidance for Pulse Oximeters (March 4, 2013). SpO2 data will be evaluated during non-motion conditions. SpO2 data will be evaluated during stable step plateaus of induced hypoxic levels. The investigational device will be placed on the thorax of the subjects (patch on the upper back and external electrode on the right pectoral). Simultaneous data collection will be set up for the reference and the systems under test.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypoxia

Keywords

Hypoxia, Pulse Oximetry, SpO2, Remote monitoring, Connected device, Real-time monitoring

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Controled Hypoxia - Healthy volunteer

Arm Type

Other

Arm Description

Male and female subjects, ranging in pigmentation from light to dark

Intervention Type

Device

Intervention Name(s)

Pulse Oximeter, Respiratory Rate, Heart Rate

Intervention Description

Measurement of physiological parameters

Primary Outcome Measure Information:

Title

Description

Time Frame

from device placement to device removal, assessed up to 3 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subject must have the ability to understand and provide written informed consent Subject is 18 to 50 years of age Subject must be willing and able to comply with study procedures and duration Subject is a non-smoker or who has not smoked within 2 days prior to the study. Male or female of any race Subject demographics include a range of skin pigmentations, including at least 3 darkly pigmented subjects or 15% of the subject pool, whichever is larger. Exclusion Criteria: Subject is considered as being morbidly obese (defined as BMI >39.5) Compromised circulation, injury, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor sites, tattoo in the optical path which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow subjects to participate if the condition is noted and would not affect the particular sites utilized.) Females who are pregnant, who are trying to get pregnant, (confirmed by positive urine pregnancy test unless the subject is known to be not of child-bearing potential) Subjects who have smoked in the last 2 days with COHb levels >3% as assessed with a Masimo Radical 7 (Rainbow) Subjects with known respiratory conditions (self-reported) Subjects with known heart or cardiovascular conditions (self-reported, except for blood pressure and ECG review) or with an implantable active medical device such as pacemaker or automatic defibrillator Self-reported health conditions as identified in the Health Assessment Form (self-reported) Subjects with severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors (self-reported) Unwillingness or inability to remove colored nail polish from test digits. Unwillingness to have chest or other test site shaved Other known health condition, should be considered upon disclosure in health assessment form

Facility Information:

Facility Name

Clinimark LLC

City

Louisville

State/Province

Colorado

ZIP/Postal Code

80027

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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RDS MultiSense® SpO2 Calibration

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