The Sunrise SpO2 and Pulse Rate Accuracy Validation Study

NCT05386836 | Completed

• 1 other identifier: PRO-367
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the SpO2 accuracy performance of the Sunrise Sensor 2 placed at the tip of the chin during non-motion conditions over the range of 70-100% by comparison to SaO2 values determined from arterial blood sample specimen analyzed by a CO-oximeter. Testing is conducted under normal office environment conditions. It is expected that the Accuracy Root Mean Square (ARMS) performance of the oximetry system will meet the required specification of ARMS of 3.5% or less allowed for reflectance technology in non-motion conditions for the range of 70-100% SaO2. A secondary goal is to evaluate the pulse rate performance simultaneously collected over the SpO2 range covered.

Conditions

Validation Study

Outcome Measures

Primary Outcomes (1)

• SpO2 ARMS determination

  SpO2 accuracy root-mean-square (ARMS) determination for the range of 70- 100%., i.e., the RMS difference between measured values and reference values.

  Within 1 month after subject recruitment

Secondary Outcomes (1)

• Pulse rate ARMS determination

  Within 1 month after subject recruitment

Study Arms (1)

Healthy adult volunteers

EXPERIMENTAL

All subjects within this single arm of the study will undergo the validation experiment as described in the description

Device: Pulse oximeter validation population

Interventions

Pulse oximeter validation population DEVICE

Evaluation of the SpO2 accuracy performance of the Sunrise Sensor 2 placed at the tip of the chin during non-motion conditions over the range of 70-100% by comparison to SaO2 values determined from arterial blood sample specimen analyzed by a CO-oximeter.

Healthy adult volunteers

Eligibility Criteria

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

You may qualify if:

• Subjects with positive Allen's test
• 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
• % of the study population or 2 subjects (whichever is larger) with dark pigmented skin should be included in the study

You may not qualify if:

• Subject is considered as being morbidly obese (defined as BMI \>39.5)
• Females who are pregnant, who are trying to get pregnant, or have a urine test positive for pregnancy on the day of the study
• Subjects with known heart or cardiovascular conditions
• Subjects with other known health condition (diabetes, thyroid disease, kidney disease/chronic renal impairment, history of seizures (except childhood febrile seizures) or epilepsy, or unexplained syncope, recent history of frequent migraine headaches, recent head injury, cancer/chemotherapy)

Sponsors & Collaborators

• Sunrise: lead

Study Sites (1)

Respisom

Namur, Belgium

Location

Study Design

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

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: May 23, 2022
• Study Start: May 24, 2022
• Primary Completion: June 21, 2022
• Study Completion: June 21, 2022
• Last Updated: June 28, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)