RDS MultiSense® SpO2 Calibration

NCT05466942 | Completed FDA Device

• 1 other identifier: PR 2022-465
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoxia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

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

Study Arms (1)

Controled Hypoxia - Healthy volunteer

OTHER

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

Device: Pulse Oximeter, Respiratory Rate, Heart Rate

Interventions

Pulse Oximeter, Respiratory Rate, Heart Rate DEVICE

Measurement of physiological parameters

Controled Hypoxia - Healthy volunteer

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rhythm Diagnostic Systems: lead
• Clinimark, LLC: collaborator

Study Sites (1)

Clinimark LLC

Louisville, Colorado, 80027, United States

Location

MeSH Terms

Conditions

Hypoxia

Interventions

Respiratory Rate; Heart Rate

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Hemodynamics; Cardiovascular Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2022
• First Posted: July 20, 2022
• Study Start: March 15, 2022
• Primary Completion: March 17, 2022
• Study Completion: October 20, 2022
• Last Updated: December 19, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)